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Results for “OPHTHALMIC SOLUTIONS”

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PubMed2002

A comparison of the relative clinical efficacy of a single dose of ketotifen fumarate 0.025% ophthalmic solution versus placebo in inhibiting the signs and symptoms of allergic rhinoconjunctivitis as induced by the conjunctival allergen challenge model.

BACKGROUND: Ketotifen fumarate 0.025% ophthalmic solution is an antiallergic treatment currently available in the United States. It is indicated for the temporary prevention of ocular itching due to allergic conjunctivitis. OBJECTIVE: The purpose of this study was to determine the relative efficacy of ketotifen when applied topically to the eye, compared with placebo, in the treatment of nasal signs and symptoms of allergic rhinoconjunctivitis as induced by the conjunctival allergen challenge (CAC) model. METHODS: This was a randomized, double-blind, parallel-group, single-center clinical study using the CAC model. Patients aged > or = 18 years, able to follow the study instructions, willing to avoid disallowed medications, and having a history of rhinoconjunctivitis and a positive skin test were eligible. At visit 1, the dose of allergen necessary to achieve a qualifying reaction was determined using bilateral ocular instillation of allergen to eligible patients. At visit 2, the allergen dose determined at visit 1 was confirmed, and all patients attaining a qualifying nasal reaction continued in the study. At visit 3, each patient was randomized to receive 1 drop of ketotifen bilaterally in the eyes or 1 drop of placebo bilaterally. Fifteen minutes after instillation of the study medication, bilateral CAC was performed. Patients rated nasal symptoms (sneezing, rhinorrhea and postnasal drip, nasal pruritus, palatal pruritus, and nasal congestion) on standardized scales at 10, 20, and 30 minutes after CAC. RESULTS: Thirty-two patients (16 men, 16 women; mean age, 45 years [range, 28-70 years]) were randomized to treatment and completed the study. Nineteen patients received ketotifen and 13 received placebo. Nasal symptom scores in ketotifen-treated patients were statistically and clinically significantly fewer than in those treated with placebo at all time points (mean baseline corrected total nasal score: 10 minutes, P = 0.010; 20 minutes, P = 0.025; 30 minutes, P = 0.006). CONCLUSION: In this study, topical ketotifen fumarate 0.025% ophthalmic solution, when dosed ocularly, offered protecdon against the nasal signs and symptoms of acute allergic rhinoconjunctival reaction as induced by the CAC model.

Adult↗

PubMed2003

Randomized, double-masked comparison of olopatadine ophthalmic solution, mometasone furoate monohydrate nasal spray, and fexofenadine hydrochloride tablets using the conjunctival and nasal allergen challenge models.

BACKGROUND: It is presumed that exposure to allergens in the environment occurs through both the eyes and the nose. Allergic rhinoconjunctivitis is typically treated with a nasal spray or systemic antihistamine, neither of which may provide adequate relief of the ocular component of the disease. OBJECTIVE: This study was designed to gain a better understanding of the physiologic interaction between the conjunctival and nasal mucosa and thus help establish a profile for the most effective ocular treatment in patients whose allergies have both an ocular and a nasal component. METHODS: This was a single-center, randomized, double-masked clinical study using the conjunctival allergen challenge (CAC) and nasal allergen challenge (NAC) models. It compared the clinical signs and symptoms induced by CAC and NAC, the effects of drugs administered by 3 different routes, and the movement of fluorescein after instillation into the eye and nose (Jones test), and assessed levels of of inflammatory mediators in tears and nasal secretions. At visit l, subjects previously identified as CAC responders underwent NAC to determine the dose of allergen necessary to elicit a sufficient positive reaction. At visit 2, which took place 1 week later, subjects with a positive reaction at visit 1 were randomized to group A (CAC) or group B (NAC), and underwent challenge to confirm the allergen dose necessary to produce a positive reaction. Subjects who qualified were randomized to receive 1 of 3 treatments: olopatadine 0.1% ophthalmic solution, placebo nasal spray, and placebo tablets; mometasone furoate monohydrate 50-microg nasal spray, placebo topical solution, and placebo tablets; or fexofenadine hydrochloride 180-mg tablets, placebo topical solution, and placebo nasal spray. All study medications were administered according to their approved labeling: drops were administered twice daily in the eyes, and the nasal sprays and tablets were administered once daily. At visit 3, which took place 1 week after visit 2, subjects received study medication and 15 minutes later underwent CAC or NAC as before. The primary efficacy variables were ocular itching, ocular redness, and overall nasal symptoms (sneezing, rhino rrhea/postnasal drip, nasal pruritus, palatal pruritus, and nasal congestion) rated on standard scales. Peak nasal inspiratory flow (PNIF) was measured at each visit, and the Jones test was performed at visits 1 and 3. At baseline and after challenge at visits 2 and 3, tear and nasal lavage samples were collected from a subset of randomly selected subjects for analysis of eosinophil cationic protein and tryptase. RESULTS: Seventy-three subjects (42 women, 31 men; mean age, 45.26 years [range, 21-73 years]) were screened, and all were randomized to treatment. Two subjects did not complete the study. CAC induced clinically significant (>1 unit difference) ocular and nasal signs and symptoms, whereas NAC induced clinically significant nasal signs and symptoms only. In group A, there was a greater reduction in ocular itching with olopatadine compared with mometasone and fexofenadine at 3 minutes (P = 0.003 and P = 0.008, respectively) and 5 minutes (P = 0.007 and P = 0.013) after challenge. Although the difference was not statistically significant, overall relief of conjunctival redness (average of 3 vessel beds) was greatest in the olopatadine group, followed by fexofenadine. In group B, prevention of total nasal symptoms was significantly greater with mometasone compared with fexofenadine at 20 minutes (P = 0.006) and 30 minutes (P = 0.014) after challenge. There were no statistically significant differences between treatment groups in nasal symptom scores at any time point after CAC. There were also no significant differences in PNIF between treatment groups. Fluorescein was present in nasal secretions within 5 minutes of being instilled into the eye; no fluorescein was detected in the eye after instillation into the nose. CONCLUSIONS: In this study, exposure of the nasal mucosa to allergen resulted in allergic rhinitis, and exposure of the ocular the ocular surface to allergen resulted in conjunctivitis with a secondary effect in the nose. These results suggest movement of allergens, their mediators, and antiallergy drugs from the ocular surfaces into the nasal cavity, with no meaningful movement from the nasal cavity to the ocular surface. In this controlled model, both the systemic agent and the nasal spray failed to control ocular symptoms. The topical ophthalmic solution provided the most effective management of allergic ocular signs and symptoms, and the nasal spray was most effective for nasal symptoms. Combined use of a nasal spray and topical ophthalmic solution may provide maximal relief in patients whose allergies have both ocular and nasal components.

Administration, Intranasal↗

PubMed2000

Simultaneous determination of eleven ingredients in ophthalmic solutions by cyclodextrin-modified micellar electrokinetic chromatography with tetrabutylammonium salt.

Cyclodextrin-modified micellar electrokinetic chromatography was applied to determine simultaneously 11 active ingredients in ophthalmic solutions. All the ingredients were successfully separated by using the mixed carrier system containing sodium dodecyl sulfate with beta-cyclodextrin and tetrabutylammonium phosphate. The effects of the cyclodextrin type on selectivity were also examined. Excellent separation of the all ingredients was obtained by the use of dimethyl-beta-cyclodextrin. The established method was validated and confirmed to be applicable to the determination of the active ingredients in a commercial ophthalmic solution. These results suggest that capillary electrophoresis can be applied to the quantitative analysis as well as qualitative analysis in pharmaceuticals.

Chromatography, Micellar Electrokinetic Capillary↗

PubMed1999

Ketorolac tromethamine 0.5% ophthalmic solution in the treatment of moderate to severe ocular inflammation after cataract surgery: a randomized, vehicle-controlled clinical trial.

PURPOSE: To investigate the efficacy and safety of ketorolac tromethamine 0.5% ophthalmic solution (Acular; Allergan, Inc, Irvine, California) in the treatment of moderate to severe anterior segment inflammation developing after unilateral cataract surgery with intraocular lens implantation. METHODS: Only patients who exhibited moderate or greater levels of cells and flare 1 day after surgery were included in this multicenter, double-masked, randomly assigned, parallel-group study. Topical ketorolac or vehicle solution (Allergan, Inc) was administered to the treated eye four times daily, starting the day after surgery and continuing for 14 days. RESULTS: Ketorolac was significantly more effective than the vehicle solution in reducing anterior chamber cells (P < or = .030) and flare (P < or = .025), conjunctival erythema (P < or = .046), ciliary flush (P < or = .006), tearing (P < or = .012), photophobia (P < or = .014), and pain (P < or = .049). Half as many patients from the ketorolac group (14/51) were discontinued from the study for lack of efficacy, compared with the vehicle group (28/51; P = .005). There was no significant difference between ketorolac and the vehicle solution in changes in visual acuity, intraocular pressure, biomicroscopic or ophthalmoscopic variables, or adverse events. CONCLUSIONS: Ketorolac tromethamine 0.5% ophthalmic solution is safe and provides substantial anti-inflammatory activity in the treatment of moderate to severe anterior segment inflammation developing after cataract surgery and intraocular lens implantation.

Adult↗

PubMed2005

Comparison of the effects of ketotifen fumarate 0.025% and olopatadine HCl 0.1% ophthalmic solutions in seasonal allergic conjunctivities: a 30-day, randomized, double-masked, artificial tear substitute-controlled trial.

BACKGROUND: Topical antiallergic agents, such as antihistamines and mast-cell stabilizers, are the main therapeutic options for seasonal allergic conjunctivitis (SAC). Ketotifen fumarate and olopatadine HCl have dual action that offers a combination of these 2 mechanisms. Although clinical studies comparing the efficacy of these 2 drugs have shown that both were effective in the treatment of SAC, the results were contradictory and did not include the effects of these drugs on inflammatory markers. OBJECTIVES: The aims of this study were to compare the clinical efficacy of topical ketotifen and olopatadine eye drops and to determine the effects of these 2 drugs on the expression of cell adhesion molecules (CAMs) and inflammatory markers in conjunctival surface cells in patients with SAC. METHODS: This 30-day, randomized, double-masked, artificial tear substitute (ATS)-controlled clinical trial was conducted at the Department of Ophthalmology, Karadeniz Technical University, School of Medicine, Trabzon, Turkey. Patients with SAC were included in the study and randomly assigned to 1 of 3 groups: topical ketotifen fumarate 0.025% ophthalmic solution, topical olopatadine HCl 0.1% ophthalmic solution, or ATS (control group). All drugs were administered 2 drops per eye BID for 30 days. At the beginning of the study (day 0; baseline), on day 15, and on day 30, clinical scores (itching, tearing, redness, eyelid, swelling, and chemosis) and conjunctival impression cytology specimens were obtained. The percentages of cells expressing intercellular adhesion molecule 1, vascular CAM-1, human leukocyte antigen-DR, and beta1-integrin (CD29) from conjunctival impression cytology specimens were determined using flow cytometry. Patients were questioned about adverse events (AEs) at each visit. Ocular discomfort on installation of the drugs was recorded as an AE. RESULTS: Thirty-nine patients (20 men, 19 women; age range, 18-61 years) with SAC were included. Twelve patients received ketotifen; 13, olopatadine; and 14, ATS. In both active-treatment groups, the improvements of clinical scores (tearing and itching) were more pronounced compared with those in the ATS group, although the day-30 difference in tearing score between the olopatadine and ATS groups was not statistically significant. No significant within-group or between-group differences in mean scores for redness, chemosis, or eyelid swelling were found. The expression rates of CAMs and inflammatory markers in conjunctival surface cells were significantly more reduced with ketotifen and olopatadine compared with ATS. However, clinical and flow cytometric parameters were improved with ATS at 15 and 30 days compared with baseline. No AEs were observed during the study period. CONCLUSIONS: In this short-term study in a selected, small study population with SAC, ketotifen and olopatadine diminished the expression of CAMs and inflammatory markers on the conjunctival surface cells effectively. Both active treatments were more efficacious compared with ATS and were well tolerated.

Adolescent↗

PubMed2005

Toxicological evaluation of micafungin ophthalmic solution in rabbit eyes.

There have been no reports of the topical application of micafungin to the eye. The aim of this study was to evaluate the safety of topical instillation of 0.1% micafungin ophthalmic solution in rabbit eyes. In New Zealand white rabbits (n = 6), 50 microL of 0.1% micafungin solution was topically instilled to 1 eye, and 50 microL of sterile saline was applied to the other eye. Both eyedrops were administered hourly from 7 A.M. for 7 days. Measurements were conducted on corneal thickness, intraocular pressure, endothelial cell density, and lactate dehydrogenase (LDH) activity of tear samples. The eyes were examined slit-lamp biomicroscopically and histopathologically. Topical micafungin application for 1 week did not induce any changes in intraocular pressure, endothelial cell density, and tear LDH. Corneal thickness after instillation was slightly, but significantly, smaller in the micafungin group than in the control group (P = 0.0156, paired t test), but this difference disappeared within 24 hours after the final instillation. Biomicroscopy and histopathology revealed no significant toxic influence of micafungin application on the cornea. Topical instillation of micafungin solution had no apparent toxicity to the cornea. These results warrant future studies on the efficacy of micafungin ophthalmic solution against corneal fungal infection.

Animals↗

PubMedDate not supplied

Clinical evaluation of ketorolac tromethamine 0.5% ophthalmic solution for the treatment of seasonal allergic conjunctivitis.

We evaluated 148 patients with allergic conjunctivitis in a double-masked, paired comparison clinical trial comparing ketorolac 0.5% ophthalmic solution with vehicle. Patients received one drop of each study medication in preassigned eyes, four times a day, for seven days. Both treatments showed significant changes from baseline in the signs and symptoms associated with allergic conjunctivitis. Evaluations at the final visit (day 7 or 8) showed that ketorolac-treated eyes had a significant treatment response when compared to vehicle-treated eyes for conjunctival inflammation (p = 0.010), ocular itching (p = 0.006), swollen eyes (p = 0.002), discharge/tearing (p = 0.021), foreign body sensation (p = 0.035), and conjunctival injection (p = 0.016). Mean scores evaluating the overall therapeutic effect of the study treatments at the completion of the study were higher for ketorolac-treated eyes than for vehicle-treated eyes as rated by investigators (p = 0.004) and study patients (p < 0.001). Results of this study confirmed the trends of a previous study showing that ketorolac 0.5% ophthalmic solution applied topically is an effective therapy for allergic conjunctivitis.

Adolescent↗

PubMed2000

An evaluation of onset and duration of action of patanol (olopatadine hydrochloride ophthalmic solution 0.1%) compared to Claritin (loratadine 10 mg) tablets in acute allergic conjunctivitis in the conjunctival allergen challenge model.

PURPOSE: To compare the clinical efficacy of Patanol (olopatadine hydrochloride ophthalmic solution 0.1%) to Claritin (loratadine 10 mg) tablets, in the conjunctival allergen challenge model. METHODS: This was a randomized, double-masked, single center, contralateral controlled, antigen challenge model study. The concentration of allergen that elicited a positive response was determined at Visits 1 and 2 (itching > or = 2 and redness > or = 2 OU). At Visit 3, 29 subjects were randomized into two groups. Fifteen subjects received Claritin tablet and Patanol ophthalmic solution 0.1% in one eye and placebo in the contralateral eye. Fourteen subjects received placebo tablet and Patanol in one eye and placebo in the contralateral eye. One hour after drug administration, subjects were challenged with the antigen that elicited a positive response. At 3, 7, and 10 minutes, itching was subjectively evaluated. At Visit 4, the same procedure was followed as in Visit 3, but antigen challenge occurred 8 hours after drug instillation. RESULTS: Results were analyzed by eye. Eyes treated with Patanol (concomitant with placebo tablet) had significantly lower ocular itching scores when compared to eyes treated with placebo (concomitant with Claritin) at 3, 7 and 10 minutes in the onset of action evaluation (p < 0.05). Eyes treated with Patanol (concomitant with placebo tablet) had significantly lower ocular itching scores at 7 minutes and there was a statistical trend (0.05 < p < 0.1) at 10 minutes in duration of action evaluation. CONCLUSIONS: Patanol therapy was significantly more efficacious than Claritin in reducing ocular itching related to allergic conjunctivitis.

Acute Disease↗

PubMed1999

Efficacy and safety profile of ketorolac 0.5% ophthalmic solution in the prevention of surgically induced miosis during cataract surgery.

This multicenter, double-masked, randomized, parallel study compared the efficacy and safety profile of ketorolac tromethamine 0.5% ophthalmic solution with that of its vehicle in the maintenance of pupillary mydriasis during cataract surgery. A total of 176 adult patients scheduled to undergo unilateral extracapsular cataract extraction and posterior-chamber intraocular lens implantation received either ketorolac tromethamine 0.5% (n = 89) or vehicle (n = 87), starting 2 hours before surgery. One drop of study medication was instilled every 30 minutes for a total of 4 drops. No epinephrine was used in the intraoperative irrigating solution. Pupil diameter was measured with a caliper at 3 time points during surgery. To ensure participant safety, biomicroscopy, ophthalmoscopy, intraocular pressure, adverse events, and preoperative and postoperative visual acuity and refractive error were also monitored. The mean change in horizontal and vertical pupil diameter from the time of the first incision to after cortical irrigation and aspiration was significantly less with active ketorolac than with vehicle (P < or = 0.014). Consequently, mean pupil diameter after cortical irrigation and aspiration was significantly greater with ketorolac than with vehicle (P < or = 0.030). No significant between-group differences were observed in the change in pupil diameter between the end of surgery and postoperative administration of a miotic agent, safety variables, or occurrence of adverse events. In this study, ketorolac tromethamine 0.5% ophthalmic solution provided effective and well-tolerated inhibition of surgically induced miosis during cataract surgery.

Aged↗

PubMedDate not supplied

Twice-daily and once-daily nedocromil sodium 2% ophthalmic solution for the treatment of seasonal allergic conjunctivitis.

In this 8-week open-label, prospective study, 30 patients with grass pollen allergy and ocular itching instilled nedocromil sodium 2% ophthalmic solution twice daily for a 5-day baseline period, followed by once-daily dosing thereafter. Physicians assessed clinical signs after the twice-daily period and after weeks 1 and 3 of the once-daily period; patients rated ocular symptoms daily. Use of specified rescue medication was permitted. Symptom scores for ocular itching, stinging, redness, swelling, burning, tearing, and light sensitivity did not differ significantly between the dosage periods. Scores for erythema, edema, conjunctival injection, and the entire conjunctiva decreased slightly during once-daily administration; discharge scores were unchanged. Of the 20 patients who used rescue medication, only 5 increased their usage by more than two doses per week during the once-daily period. Eighty-three percent of patients were willing to continue the once-daily regimen during the next allergy season. Physicians rated overall control of seasonal allergic conjunctivitis with once-daily administration as "good" or "moderate" in 100% of the patients; 93% of patients applied those ratings themselves. Nedocromil sodium 2% ophthalmic solution instilled once daily maintains control of symptoms in patients who are established on a twice-daily regimen.

Adolescent↗

PubMedDate not supplied

Double-masked, paired-comparison clinical study of ketorolac tromethamine 0.5% ophthalmic solution compared with placebo eyedrops in the treatment of seasonal allergic conjunctivitis.

In a multicenter, double-masked, clinical study, we compared the ocular safety and efficacy of ketorolac 0.5% ophthalmic solution with placebo in alleviating the signs and symptoms of allergic conjunctivitis. The study was conducted in 93 patients who received one drop of the appropriate treatments in each eye, four times a day, for seven days. Of these subjects, 74 were evaluated for efficacy. The principal clinical sign of allergic conjunctivitis, conjunctival inflammation, and six allergic symptoms (itching, swollen eyes, burning or stinging, discharge or tearing, foreign body sensation, and photophobia) were evaluated by the investigators at midweek (day 3 or 4) and at the end of the study (day 7 or 8). Ketorolac was superior to placebo in reducing conjunctival inflammation (p = 0.003) and itching (p = 0.020), the principal clinical symptom, at the final examination. In addition, ketorolac was favored over placebo in reducing the other five symptoms evaluated. On the day of final examination, overall therapeutic response evaluated by the investigators rated ketorolac as superior to placebo (p = 0.007). A significant placebo effect was noted in this study, as has been previously reported in clinical studies of allergic conjunctivitis patients. Results of this study demonstrate that 0.5% ketorolac ophthalmic solution used topically four times daily, for seven days, was effective in alleviating the principal sign and the symptoms associated with allergic conjunctivitis.

Adult↗

PubMed2004

Efficacy and safety of single- and multiple-dose ketotifen fumarate 0.025% ophthalmic solution in a pediatric population.

Allergic conjunctivitis can seriously disrupt children's daily activities. This study assessed the efficacy (onset and duration of action) and safety of ketotifen fumarate 0.025% ophthalmic solution compared with vehicle placebo in pediatric subjects after single and multiple dosing. This was a double-masked, multicenter, fellow-eye, placebo-controlled, conjunctival allergen challenge trial. Eligible subjects (8-16-yr-olds) who produced a qualifying reaction to allergen were randomized to a single dose (one drop) of ketotifen fumarate in one eye and vehicle placebo in the fellow eye, followed by an allergen challenge at 15 min and 8 h post-dose. Subjects who had a qualifying reaction to allergen in the placebo-treated eye and a qualifying response to ketotifen in the active-treated eye following the single dose were re-randomized to a multiple-dose treatment period. They were instructed to instill one drop of ketotifen fumarate in one eye and placebo in the other eye twice daily for 4 wk. An allergen challenge was conducted 8 h after the last dose. The primary efficacy assessment was ocular itching, judged by the subject at 3, 7, and 10 min post-allergen challenge after single- and multiple-dose treatments. Other ocular signs and symptoms were assessed at 7, 10, and 15 min post-dose. A total of 133 subjects were randomized to single-dose treatment; 105 were evaluable for efficacy. Of these, 60 were re-randomized to multiple-dose treatment, and 55 were evaluable for efficacy. After single and multiple doses, ketotifen fumarate significantly inhibited ocular itching compared with placebo at all post-challenge timepoints (p < 0.001) and also significantly reduced hyperemia, chemosis, and lid swelling (p = 0.031). No drug-related systemic adverse events were reported, and ocular adverse events were comparable to placebo. No subject discontinued prematurely due to an adverse event. These results indicate that ketotifen fumarate 0.025% ophthalmic solution is an effective and safe treatment option for children with allergic conjunctivitis.

Adolescent↗

PubMed1976

Pilocarpine hydrochloride in ophthalmic solutions: modification of a high-pressure liquid chromatographic determination and survey.

Pilocarpine undergoes 2 important reactions in solutions, epimerization to isopilocarpine and hydrolysis to pilocarpic acid. There is no official USP limit for isopilocarpine or pilocarpic acid in pilocarpine hydrochloride ophthalmic solutions. An existing high-pressure liquid chromatographic (HPLC) method was modified by changing the buffer system to permit its use with constant-pressure as well as constant-volume instruments. The procedure separates all 3 components on a cation exchange resin; pilocarpine and isopilocarpine are determined directly and pilocarpic acid indirectly. Ophthalmic solutions and drug substances were obtained from substantially all the United States marketers of pilocarpine opthalmic solutions and were analyzed by the modified HPLC method. Results of the survey show that isopilocarpine is present to the extent of 0.4-3% and pilocarpic acid at levels of 0.6-7% of total alkaloid.

Chemical Phenomena↗

PubMed2006

Topical brimonidine 0.2%/timolol 0.5% ophthalmic solution: in glaucoma and ocular hypertension.

A fixed combination of brimonidine (a highly selective alpha(2)-adrenergic agonist) and timolol (a non-selective beta-blocker) [brimonidine 0.2%/timolol 0.5% ophthalmic solution; brimonidine/timolol] is available for the topical treatment of glaucoma and ocular hypertension (OH). Brimonidine and timolol decrease elevated intraocular pressure (IOP) by complementary mechanisms of action and have an additive effect when coadministered to healthy volunteers and patients with glaucoma or OH. When assessed over a 3- or 12-month period in large, well designed clinical studies, brimonidine/timolol instilled twice daily (one drop in each eye) was superior to monotherapy with the individual components instilled two (brimonidine) or three (timolol) times daily, and noninferior to concomitant therapy with the individual components instilled twice daily, in lowering raised IOP in patients with glaucoma or OH. In small, randomised, comparative studies of 1 or 3 months' duration, the IOP-lowering effect of brimonidine/timolol twice daily was similar or superior to that of fixed combination dorzolamide 2%/timolol 0.5% ophthalmic solution (dorzolamide/timolol) twice daily (preliminary data). Brimonidine/timolol is generally well tolerated with a predictable local and systemic adverse event profile based on that of the individual components used alone and concomitantly. No unexpected or serious adverse events associated with the fixed combination were reported in key clinical trials. Brimonidine/timolol may be advantageous over dorzolamide/timolol with respect to ocular tolerability and comfort (preliminary data).

Antihypertensive Agents↗

PubMed1984

Treatment of seasonal conjunctivitis: comparison of 2% and 4% sodium cromoglycate ophthalmic solutions.

In a double-blind, noncrossover, group study a 2% ophthalmic solution of sodium cromoglycate (Opticrom) was compared with a 4% solution in the treatment of ragweed-pollen-induced conjunctivitis. The 22 female and 18 male patients, ranging in age from 10 to 61 years, had a history of troublesome eye symptoms during the ragweed season for at least 2 years and had previously obtained minimal relief with the 2% solution. They were randomly assigned to two treatment groups in matched pairs and instructed to use one drop of the medication in each eye four times a day for 4 weeks. Treatment efficacy was evaluated from the patients' daily diaries, periodic clinical assessments and subjective reports by the patients at the end of the trial. Analysis of the symptom severity scores and evaluations by both the patients and the clinician indicated that the 4% solution was more effective than the 2% solution in controlling the symptoms. No local or systemic side effects were encountered.

Adolescent↗

PubMed2005

Quantitative analysis of chondroitin sulfate in raw materials, ophthalmic solutions, soft capsules and liquid preparations.

We performed the quantitative analysis of chondroitin sulfate (CS) obtained from raw materials and various pharmaceutical preparations. To quantify CS content in raw materials and in an ophthalmic solution, each test sample and the authentic CS were first digested by chondroitinase ABC. The CS disaccharides produced were analyzed by strong anion-exchange high-performance liquid chromatography (SAX-HPLC) and CS content was quantified by calculating the total peak areas of the disaccharides derived from a CS calibration curve. In the case of soft capsules, CS was first extracted with hexane followed by phenol-chloroform to remove oil and protein ingredients. The extracted CS samples were depolymerized by chondroitinase ABC and CS content was determined. Quantitative analysis of the disaccharides derived from raw materials and an ophthalmic solution showed the CS contents (%) were 39.5+/-0.1 to 105.6+/-0.1 and 103.3+/-1.2, respectively. In case of CS analysis in soft capsules and liquid preparations, the overall recovery (%) of the spiked CS was 96.79+/-0.53-103.54+/-1.78 and 97.10+/-1.82 to 103.17+/-2.34, respectively. In conclusion, the quantitative analysis of the disaccharides produced by enzymatic digestion can be used in the direct quantitation of CS containing pharmaceutical formulations.

Animals↗

PubMed1993

[Effect of tranilast ophthalmic solution on allergic conjunctivitis in guinea pigs].

The effect of the ophthalmic solution of tranilast, an anti-allergic agent, on allergic conjunctivitis was studied in passively sensitized guinea pigs. We determined the content of uranine dye and histamine in tears and histopathologically examined palpebral conjunctiva. After instillation of antigen into the conjunctival sac, inflammation of the palpebral conjunctiva, an increase in leaked dye and the release of histamine were found. In the histopathological study, tranilast (1.0%) suppressed the appearance of edema and infiltration of inflammatory cells. Tranilast suppressed the leakage of uranine in a dose-dependent manner. A 0.5% solution of diphenhydramine also showed the inhibitory effect on the leakage of uranine. The inhibitory effect of 0.5% tranilast on antigen-induced dye leakage and histamine release lasted for 6 hr. These results suggest that topically applied tranilast is effective for allergic conjunctivitis.

Animals↗

PubMed1996

Comparison of ciprofloxacin ophthalmic solution 0.3% to fortified tobramycin-cefazolin in treating bacterial corneal ulcers. Ciprofloxacin Bacterial Keratitis Study Group.

PURPOSE: The purpose of the study is to compare the clinical efficacy and safety of ciprofloxacin ophthalmic solution 0.3% (Ciloxan) with a standard therapy regimen (fortified tobramycin, 1.3%-cefazolin, 5.0%) for treating bacterial corneal ulcers. METHODS: This randomized, parallel group, double-masked, multicenter study was conducted in 324 patients at 28 centers in the United States, Europe, and India. Patients were randomized into 2 treatment groups: 160 to ciprofloxacin and 164 to fortified tobramycin-cefazolin. Positive microbiologic cultures were obtained in 188 (58%) of 324 patients. Of these, 176 patients met protocol criteria and were evaluated for treatment efficacy: 82 in the ciprofloxacin group and 94 in the standard therapy group. The dosing schedule for both treatment groups was 1 to 2 drops of the first study medication (ciprofloxacin or fortified tobramycin) every 30 minutes for 6 hours, then hourly for the remainder of day 1; 1 to 2 drops every hour on days 2 and 3; 1 to 2 drops every 2 hours on days 4 and 5, followed by 1 to 2 drops every 4 hours on days 6 to 14. The second medication (ciprofloxacin or cefazolin) was instilled 5 to 15 minutes after the first drug, following the same dosing frequency. Physician's judgment of clinical success, cure rate, changes in ocular sings, and symptoms and the rate of treatment failures were the primary efficacy criteria. RESULTS: Topical ciprofloxacin monotherapy is equivalent clinically and statistically to the standard therapy regimen of fortified antibiotics. No statistically significant treatment differences were found between ciprofloxacin (91.5%) and standard therapy (86.2%) in terms of overall clinical efficacy (P = 0.34). Similarly, no differences were noted in resolution of the clinical signs and symptoms (P > 0.08) or the time to cure (P = 0.55). The incidence of treatment failures was less in the ciprofloxacin group (8.5%) compared with the standard therapy group (13.8%). Significantly fewer patients treated with ciprofloxacin reported discomfort than did patients treated with the standard therapy regimen (P = 0.01). CONCLUSION: Ciprofloxacin ophthalmic solution 0.3% monotherapy is equivalent clinically and statistically to standard therapy (fortified tobramycin-cefazolin) for the treatment of bacterial corneal ulcers and produces significantly less discomfort.

Adolescent↗