Global experience with Xibrom (bromfenac ophthalmic solution) 0.09%: the first twice-daily ophthalmic nonsteroidal anti-inflammatory drug.
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Animals↗
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Results for “OPHTHALMIC SOLUTIONS”
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[TPD ophthalmic solution (mixture of tropicamide, phenylephrine hydrochloride, and diclofenac sodium) for cataract surgery].
PURPOSE: We made a TPD ophthalmic solution by combining tropicamide solution(Mydrin-P: T), phenylephrine hydrochloride(Neosynesin Kowa: P) and diclofenac sodium(Diclod: D), and evaluated its efficiency in mydriasis during cataract surgery compared to T, P, and D. SUBJECTS AND METHODS: Twenty-five eyes(19 patients) were given either TPD solution(10 eyes) or T, P, and D solution(15 eyes), and the treatment was given six times before surgery. Pupil diameters were measured before and after surgery. RESULT: The operation time was 10.0 +/- 5.2(mean +/- standard deviation) minutes in the TPD group, and 9.0 +/- 3.6 minutes in the T, P and D group. The preoperative and postoperative one pupil diameter was 8.65 +/- 0.34 mm and 8.20 +/- 0.35 mm in the TPD group and 8.80 +/- 0.49 mm and 8.37 +/- 0.61 mm in the T, P, and D group, respectively. The rate of miosis was 5.1 +/- 4.2% in the TPD group and 4.8 +/- 5.1% in the T, P, and D group, respectively. There was no statistically significant difference between the two groups. CONCLUSION: TPD ophthalmic solution maintains the mydriasis as potent by as T, P and D solution.
Aged↗
A phase III, placebo controlled clinical trial of 0.5% levofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis.
AIM: To compare the efficacy and safety of levofloxacin 0.5% ophthalmic solution (Quixin) with placebo for treatment of bacterial conjunctivitis. METHODS: In this prospective, randomised, placebo controlled, double masked, multicentre study, 249 patients with bacterial conjunctivitis received either 0.5% levofloxacin (n = 126) or placebo (n = 123) for 5 days, administered every 2 hours on days 1-2, then every 4 hours on days 3-5. Cultures were obtained and signs/symptoms evaluated at baseline, interim, and final visits. The end point was the last evaluable observation. Primary microbial outcomes were based on culture results; clinical outcomes were based on resolution of cardinal signs. RESULTS: 117 patients (60 levofloxacin, 57 placebo) were evaluated. Microbial eradication rates were significantly greater with levofloxacin at all time points, reaching 90% at end point. In a subgroup analysis, differences in eradication rates at end point were most pronounced in children but were also statistically significant for levofloxacin in adults. Clinical cure rates were significantly greater with levofloxacin at final visit and end point. Statistically significant differences favouring levofloxacin were measured at end point for resolution of conjunctival discharge, bulbar conjunctival injection, palpebral conjunctival injection, burning/stinging, itching, and photophobia. Adverse events were similar between groups. Safety composite scores analysed by age indicated significantly fewer children on levofloxacin experienced worsening symptoms. CONCLUSIONS: Levofloxacin 0.5% ophthalmic solution is safe and effective for treatment of bacterial conjunctivitis.
Adolescent↗
Topical ketorolac tromethamine 0.5% ophthalmic solution in ocular inflammation after cataract surgery.
PURPOSE: To compare the efficacy and safety of ketorolac 0.5% ophthalmic solution with its vehicle in the treatment of ocular inflammation after cataract surgery and intraocular lens implantation. DESIGN: Multicenter clinical study. PARTICIPANTS: One hundred four patients were prospectively randomized, 52 patients in treatment group, 52 patients in control group. METHODS: Patients received either ketorolac or vehicle four times daily in the operated eye for 14 days starting the day after surgery in a prospective, double-masked, randomized, parallel group study. Only patients with moderate or greater postoperative inflammation the day after surgery were enrolled. MAIN OUTCOME MEASURES: The main outcome measures include inflammation (cell, flare, ciliary flush), intraocular pressure and visual acuity. RESULTS: Ketorolac was significantly more effective than vehicle in reducing the manifestations of postoperative ocular inflammation, including: anterior chamber cells (P: = 0.002) and flare (P: = 0.009), conjunctival erythema (P: = 0.010), ciliary flush (P: = 0.022), photophobia (P: = 0.027), and pain (P: = 0.043). Five times as many patients were dropped from the study for lack of efficacy from the vehicle group (22/52) than from the ketorolac group (4/52; P: = 0.001). Ketorolac was found to be equally as safe as vehicle in terms of adverse events, changes in visual acuity, intraocular pressure, and biomicroscopic and ophthalmoscopic variables. CONCLUSIONS: Ketorolac tromethamine 0.5% ophthalmic solution was significantly more effective than vehicle in the treatment of moderate or greater ocular inflammation following routine cataract surgery, while being as safe as vehicle.
Administration, Topical↗
Effect of pirenzepine ophthalmic solution on form-deprivation myopia in the guinea pigs.
BACKGROUND: Nonselective muscarinic receptor antagonist, atropine, was believed to inhibit myopic progression. The purpose of this study was to determine the efficacy, through topical administration, of the M1-selective muscarinic antagonist pirenzepine in preventing experimentally induced form-deprivation myopia in guinea pigs. METHODS: Fifty-three guinea pigs, which underwent monocular deprivation with their eyelids sutured, were divided into 6 groups. Three groups were treated with 1%, 2% or 4% pirenzepine ophthalmic solutions; the fourth group with atropine; the fifth with saline and the last group left untreated. Ocular refraction, in vivo biometric measurements and wet eye weight were collected before and after the experiment. All the eyes were finally enucleated for histopathological examination to evaluate the possible toxic effects on ocular structures. RESULTS: Animals untreated or treated with saline produced (-2.31+/-1.47) D and (-2.25+/-0.88) D of axial myopia respectively. Those treated with 1% pirenzepine ophthalmic solution produced relative myopia of (-1.63+/-0.48) D, and those under the treatment of 2% and 4% pirenzepine ophthalmic solution only developed a relative myopia of (-0.89+/-0.42) D and (-0.70+/-0.41) D (F=9.56, P<0.05). The significant reduction in myopia in 2% and 4% pirenzepine treated animals was caused by significantly less vitreous chamber elongation and axial elongation of the deprived eyes [2% group: (0.009+/-0.052) mm, 4% group: (0.006+/-0.078) mm] when compared with untreated, saline treated or 1% pirenzepine treated guinea pigs (0.057+/-0.056) mm, (0.064+/-0.053) mm and (0.033+/-0.035) mm, respectively]. Histological examinations revealed no obviously toxic effects on the eyes treated with pirenzepine. CONCLUSION: Topical administration of the M1-selective muscarinic antagonist, pirenzepine, can prevent induced form-deprivation myopia in guinea pigs by inhibiting axial elongation without obvious damage to ocular tissues.
Animals↗
Results of a survey of children with acute bacterial conjunctivitis treated with trimethoprim-polymyxin B ophthalmic solution.
Acute conjunctivitis, one of the most frequently seen eye diseases in infants and children, is associated with a shorter duration of clinical disease when antimicrobial agents are used. Although viruses often are implicated as causative agents, Haemophilus influenzae and Streptococcus pneumoniae are the most commonly isolated bacterial pathogens. Empiric therapy of acute conjunctivitis therefore should include agents with both gram-positive and gram-negative antimicrobial activity. Trimethoprim-polymyxin B is a broad-spectrum antimicrobial agent available as an ophthalmic solution. We conducted a patient outcomes study to evaluate the subjective response to treatment with trimethoprim-polymyxin B of children with presumed acute bacterial conjunctivitis. Questionnaires were distributed to more than 100 pediatricians who assessed outcome measures in 472 children with acute bacterial conjunctivitis for whom they prescribed trimethoprim-polymyxin B. The parameters evaluated were clinical outcome, overall efficacy, and comfort provided by the medication regimen. The physicians reported that 95% of the infected eyes were cured or improved within 7 days. In addition, the overall efficacy trimethoprim-polymyxin B was rated as excellent or good in 76% and 20% of cases, respectively. With regard to patient comfort, patients or their caregivers reported that patients were very comfortable or moderately comfortable in 62% and 27% of cases, respectively. Four adverse events were reported; all were transient and of mild-to-moderate intensity. The survey results support clinical research findings on the comparative efficacy and safety of trimethoprim-polymyxin B ophthalmic solution compared with other ophthalmic antimicrobial agents. The pediatricians in our survey who prescribed trimethoprim-polymyxin B ophthalmic solution for children with presumed acute bacterial conjunctivitis reported that this medication was effective and well tolerated.
Acute Disease↗
[Preventive effects of diclofenac ophthalmic solution on post-cataract-surgical cystoid macular edema].
Using eyes undergoing phacoemulsification followed by implantation of a foldable acrylic intraocular lens (IOL) designed for small-incision cataract surgery, a multi-center study was performed to compare a non-steroidal ophthalmic solution (0.1% diclofenac) to a steroidal ophthalmic solution (0.1% fluorometholone) in preventing cystoid macular edema (CME) and inducing disruption of the blood-aqueous barrier determined by laser flare cellmetry. The incidence of CME, noted in 3 out of 53 eyes (5.7%) receiving diclofenac and in 29 out of 53 eyes (54.7%) receiving fluorometholone, was significantly lower in the diclofenac group. The flare in the anterior chamber was also significantly lower in the diclofenac group; when compared between eyes with and without CME, the amount of flare was significantly higher in the former group. These findings suggest that diclofenac effectively prevents CME following cataract surgery and that CME is closely related to the breakdown of the blood-aqueous barrier.
Aged↗
Antibacterial activity of the white precipitate formed on the corneal surface after treatment with ciprofloxacin ophthalmic solution.
PURPOSE: To determine the antibacterial activity of the white crystalline precipitate formed on the corneal surface after topical administration of 0.3% ciprofloxacin ophthalmic solution by microbiologic assay. METHODS: White crystalline precipitate formed on the corneal surface of seven patients was scraped and individually dissolved in sterile distilled water. Quantification by high-performance liquid chromatography (HPLC) and microbiologic assay of ciprofloxacin in the precipitate solutions were done. Microbiologic assay was performed by agar diffusion method against Klebsiella pneumoniae. RESULTS: By HPLC, concentrations of ciprofloxacin were estimated to be 1.5-60 microg/ml in the dissolved precipitate obtained from six patients, whereas the concentrations based on microbiologic assay varied from 1.6 to 16.1 microg/ml. Ciprofloxacin was not detected by either method in the precipitate obtained from one patient. The antibacterial activity (microg/ml) determined by microbiologic assay was not related to the actual amount of ciprofloxacin in the solutions as estimated by HPLC in cases 1, 2, 4, and 7. It was almost the same in the solutions from cases 5 and 6. CONCLUSION: The white crystalline precipitate formed on the corneal surface after topical administration of 0.3% ciprofloxacin ophthalmic solution exhibited bacterial inhibitory activity, indicating that the precipitate may function as a drug depot.
Adult↗
The stability of adrenaline ophthalmic solutions on sterilization and storage.
The stability of adrenaline ophthalmic solutions, at pH 5.8 and 7.4, to sterilization and storage conditions has been studied. Solutions sterilized by filtration or heating at 98 degrees C for 30 min showed no detectable degradation at either pH value, whilst sterilization at higher temperatures resulted in losses of up to 30%. Total degradation increased with increasing sterilization temperature at both pH values.
Drug Stability↗
Effect of gatifloxacin ophthalmic solution 0.3% on human corneal endothelial cell density and aqueous humor gatifloxacin concentration.
PURPOSE: To evaluate the effect of gatifloxacin ophthalmic solution 0.3% (Zymar, Allergan, Inc., Irvine, CA, USA) on corneal endothelial cell density and morphology and to measure gatifloxacin penetration into aqueous humor. METHODS: This was a single-center, open-label clinical study. Ten patients undergoing standard cataract surgery and 20 nonsurgical subjects instilled gatifloxacin 0.3% four times per day for 2 days, then every 10 min for 1 hr on the third day (the surgery day for the cataract patients). Corneal endothelial cells were counted using noncontact specular microscopy. Anterior chamber fluid was withdrawn from the surgical patients, and the gatifloxacin concentration was quantified by high-pressure liquid chromatography. RESULTS: Baseline endothelial cell counts (mean +/- SD) were 2400 +/- 442 in the surgical group and 2520 +/- 212 in the nonsurgical group. The mean differences from baseline 1 hr after the last dose of gatifloxacin 0.3% were -51 +/- 213 (p = 0.23) in the surgical group and -7 +/- 150 (p = 0.42) in the nonsurgical group. In the nonsurgical group, the mean difference from baseline 3 weeks after the last dose was 18 +/- 147 (p = 0.71). The mean concentration (+/- SD) of gatifloxacin in aqueous humor was 1.26 +/- 0.55 microg/ml. CONCLUSIONS: A preoperative, prophylactic course of gatifloxacin 0.3% ophthalmic solution did not significantly affect endothelial cell density or morphology, while meaningful drug concentration was achieved in the aqueous humor.
Administration, Topical↗
A randomized, double-blind, parallel-group comparison of olopatadine 0.1% ophthalmic solution versus placebo for controlling the signs and symptoms of seasonal allergic conjunctivitis and rhinoconjunctivitis.
BACKGROUND: The most common form of allergic ocular disease is seasonal allergic conjunctivitis, coinciding with the pollen season and generally associated with rhinitis. Symptoms of allergic conjunctivitis include ocular itching, hyperemia, tearing, mucus production, foreign body sensation, chemosis, and lid edema. Similarly, the primary symptoms of allergic rhinoconjunctivitis are nasal itching, irritation, sneezing, watery rhinorrhea, and congestion combined with ocular itching, tearing, and swelling. OBJECTIVE: This study compared olopatadine 0.1% ophthalmic solution with placebo eyedrops (over-the-counter artificial tear product), instilled in the eye, with regard to the prevention and relief of the ocular and nasal symptoms of seasonal allergic conjunctivitis and rhinoconjunctivitis. METHODS: This was a randomized, double-blind, parallel-group study, conducted at 7 US centers, to instill either olopatadine 0.1% ophthalmic solution or placebo eyedrops (artificial tears) in both eyes twice daily for 10 weeks. Patients were evaluated for efficacy (intent-to-treat) and safety. Only patients with proven grass pollen allergy (dermal and conjunctival allergen challenge tests) were selected; all patients were studied during the same period, historically shown to be grass season; and grass pollen counts were obtained. RESULTS: A total of 131 patients (64 olopatadine; 67 placebo) were assessed for efficacy (intent-to-treat); 132 patients were assessed for safety. The mean (SD) age of participants was 38.53 (11.61) years (range, 18 to 87 years), and 58.0% were women (76/131), with no significant differences between groups for age or sex. In the olopatadine group, 1.6% of patients were black (1/64), compared with 14.9% of the placebo group (10/67) (P = 0.005). Mean scores of ocular itching and hyperemia were lower at all assessment times with olopatadine than placebo. The difference was statistically significant (P < 0.05) for itching on days 7, 14, 35, 63, and 70, and for hyperemia on days 14, 28, 42, and 63, after correction for multiplicity. Linear regression slopes predicting ocular itching and hyperemia from the pollen count were significantly lower (P < 0.003 and P < 0.035, respectively) with olopatadine than with placebo. Similar results were obtained for rhinorrhea, sneezing, and nasal itching (P < 0.006, P < 0.012, and P < 0.034, respectively). With placebo, the proportion of patients with frequent ocular itching and hyperemia increased as a function of pollen level; however, with olopatadine, the proportions remained low and virtually constant. CONCLUSION: In the population studied, olopatadine 0.1% ophthalmic solution controlled ocular and nasal symptoms of allergic conjunctivitis and rhinocojunctivitis and was well tolerated when administered twice daily for 10 weeks.
Adolescent↗
Efficacy and safety of 0.5% levofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in pediatric patients.
PURPOSE: To compare the efficacy and safety of 0.5% levofloxacin ophthalmic solution (Quixin; Santen, Napa, CA) with 0.3% ofloxacin (Ocuflox; Allergan Inc., Irvine, CA) and placebo for the treatment of pediatric bacterial conjunctivitis. METHODS: This study was a subset analysis of 167 pediatric patients (age range, 1 to 16 years) from two randomized, double-masked, multicenter, parallel group studies. Eye drops were instilled every 2 hours on days 1 and 2 and every 4 hours on days 3 through 5. Ocular signs and symptoms were noted, and conjunctival cultures were obtained on day 1 (baseline), days 3 to 5 (interim), and days 6 to 10 (final). Endpoint was defined as the last evaluable observation. Microbial and clinical outcomes were based on culture results and cardinal signs, respectively. RESULTS: At endpoint (mean of 6.5 days for 118 evaluable patients), 0.5% levofloxacin treatment demonstrated greater microbial eradication rates (percentage of patients with absence of causative organisms cultured at baseline) compared with 0.3% ofloxacin or placebo. In children age 2 to 11 years, this finding was statistically significant in favor of 0.5% levofloxacin (87% vs 62% with 0.3% ofloxacin [P < or =.032] and 88% vs 24% with placebo [P <.001]). No significant differences between treatment groups in microbial eradication rates were noted in other age subgroups. CONCLUSIONS: After 5 days of therapy, 0.5% levofloxacin ophthalmic solution was found to be safe and effective in treating pediatric bacterial conjunctivitis. Treatment with 0.5% levofloxacin achieved microbial eradication rates in children that were statistically superior to those attained with 0.3% ofloxacin or placebo.
Adolescent↗
Self-medicated over the counter ophthalmic solutions in central Bangkok.
BACKGROUND: There is a paucity of research about patients' attitudes, motivations and expectations towards self-medicated over the counter (OTC) ophthalmic solutions. OBJECTIVES: To identify the attitudes, motivations and expectations of general population towards self-medicated OTC ophthalmic solutions. MATERIAL AND METHOD: 200 consecutive participants who were studying or lived in Patumwan District of Bangkok filled in a questionnaire in a 3-months period. RESULTS: 67.5% (135/200) of the participants had an age range of 15-24 years old and 32.5% (65/200) were between 25-35 years old. Participants who were university graduates and currently university students were 53% and 35.5% respectively. Most history of illness was allergy (10/200). Half of the participants had normal vision and 40% (80/200) were near-sighted. The factor that most influenced the use of solution was dust in the eye (55%-111/200). Ocular allergic symptoms, such as eye itching, irritation and tearing, was the second. The most frequent symptom that induced the use of solutions was eye itching and irritation (48.5%-97/200). The symptom of red or pink eye was the second (33%-66/200). 48.5% (97/200) and 53.50% (107/200) of participants started using the solution at the time the influencing symptoms occurred and used for one day respectively. 46.5% (93/200) of the participants realized that the solution could be use only within 1 month after opening. CONCLUSION: From the data of this survey, more information and knowledge about the use of OTC products needs to be campaigned, even among highly educated citizens in the center of Bangkok. Better information for patients could improve the safety of OTC medicines. The ways of advising patients need to be found. The uncertainty is, therefore, how far this trend will go and how health care professionals and consumers will resspond.
Adolescent↗
Effect of anti-infective ophthalmic solutions on corneal cells in vitro.
External ocular infections caused by susceptible strains of bacteria have recently been treated with potent broad-spectrum antimicrobial solutions. This study was conducted to compare the in vitro biologic effects of three anti-infective ophthalmic solutions (Ocuflox, Ciloxan, and Tobramycin) on rabbit corneal epithelial cell cultures. Epithelial cell layers from albino rabbit eyes were isolated and incubated in culture media for 9 days, following which the cultures were rinsed and treated with the anti-infective solutions. Ciloxan and Tobramycin caused extensive ethidium bromide staining of the corneal epithelial cell layer after 5, 10, and 15 minutes, indicating acute cell membrane damage. Ocuflox ophthalmic solution caused less ethidium bromide staining at all evaluated times and, therefore, less cell membrane damage than the comparator solutions.
Animals↗
Efficacy and safety of nedocromil sodium 2% ophthalmic solution b.i.d. in the treatment of ragweed seasonal allergic conjunctivitis.
The efficacy and safety of twice-daily nedocromil sodium 2% ophthalmic solution and vehicle were compared in the treatment of ragweed seasonal allergic conjunctivitis. Two separate multicenter, randomized, double-masked, placebo-controlled studies were subjected to a combined analysis. Following a one-week baseline period during the beginning of the ragweed pollen season, 189 patients with seasonal allergic conjunctivitis received either nedocromil sodium or vehicle b.i.d. for eight weeks. Efficacy was evaluated by patient diary cards and clinical eye examinations. Safety was assessed by reports of adverse events. Compared with vehicle, nedocromil sodium produced significantly greater decreases in summary symptom score (p = 0.005), itch (p = 0.005), tearing (p = 0.004), overall eye condition (p = 0.001), and clinician-evaluated conjunctival edema (p = 0.018), and significantly better (p = 0.001), and patient (p = 0.001) opinions of treatment effectiveness at the peak pollen period. Additionally, the superiority of nedocromil sodium compared to vehicle approached statistical significance in redness reduction (p = 0.087) and clinician-evaluated conjunctival injection (p = 0.087). There were no serious treatment-related adverse events in either treatment group. In summary, nedocromil sodium 2% ophthalmic solution b.i.d. was found to be effective and to have a favorable safety profile in the treatment of seasonal allergic conjunctivitis.
Adolescent↗
Comparison of ketotifen fumarate ophthalmic solution alone, desloratadine alone, and their combination for inhibition of the signs and symptoms of seasonal allergic rhinoconjunctivitis in the conjunctival allergen challenge model: a double-masked, placebo- and active-controlled trial.
BACKGROUND: Ketotifen fumarate is a topical antiallergic combination mast-cell stabilizer and antihistamine indicated for the temporary prevention of ocular itching due to allergic conjunctivitis. Desloratadine is a systemic antihistamine indicated for the treatment of seasonal and perennial allergic rhinitis. OBJECTIVE: The purpose of this study was to compare the efficacy of ketotifen 0.025% ophthalmic solution instilled in the eye, desloratadine 5-mg tablets taken orally, and their combination for prevention of the signs and symptoms of allergic rhinoconjunctivitis, as induced by the conjunctival allergen challenge (CAC) model. METHODS: This was a randomized, double-masked, placebo- and active-controlled, single-center clinical trial. At visit l, the dose of allergen necessary to elicit a qualifying allergic reaction was determined for subjects meeting the entry criteria. At visit 2, the allergen dose determined at visit 1 was confirmed, and all subjects who had a qualifying ocular and nasal allergic reaction were randomized to 1 of 3 treatment groups: ketotifen ophthalmic solution and placebo tablet, desloratadine tablet and placebo eyedrop, or ketotifen and desloratadine. Subjects were instructed to instill 1 drop into each eye twice daily and take 1 tablet with water once daily at the same time as the morning eyedrop for approximately 4 weeks. At visit 3, subjects brought in their medication and were given 1 drop of the eyedrop bilaterally and 1 tablet with water. Bilateral CAC was performed 2 hours after administration of medication. Using standardized scales, subjects rated ocular itching at 3, 5, and 7 minutes after CAC; ocular tearing and eyelid swelling at 10, 15, and 20 minutes after CAC; and nasal signs and symptoms (sneezing, rhinorrhea and postnasal drip, pruritus, and nasal congestion) at 10, 20, 30, 40, and 50 minutes after CAC. The investigator graded ocular redness and chemosis at 10, 15, and 20 minutes after CAC. At all visits, subjects were offered an anti-allergy eyedrop to relieve any immediate ocular discomfort caused by CAC. RESULTS: One hundred two subjects were screened-82 (55 women, 27 men; mean age, 42.8 years [range, 21-70 years]) were randomized to treatment, and 80 completed the study. Subjects in the group that received ketotifen (n = 27) and the group that received ketotifen with desloratadine (n = 26) had significantly lower mean itching scores compared with those in the group that received desloratadine alone (n = 27) at all time points (P </= 0.05). Total ocular redness, calculated by summing the mean redness scores for each of the 3 vessel beds, was significantly lower in the ketotifen group than in the other treatment groups at most time points (P </= 0.05). All treatments attenuated nasal symptoms; no statistically significant differences were noted between treatment groups, with the exception of the 50-minute time point, at which combination treatment was significantly more effective than ketotifen alone (P </= 0.05). The proportion of subjects who requested relief drops after CAC was significantly lower in both the ketotifen alone and combination treatment groups compared with the desloratadine alone group (P = 0.004). CONCLUSIONS: Ketotifen ophthalmic solution significantly decreased the signs and symptoms of ocular and nasal allergic rhinoconjunctivitis. The addition of ketotifen to the oral desloratadine regimen improved the overall antiallergic efficacy of both medications.
Adolescent↗
Concentration of latanoprost ophthalmic solution after 4 to 6 weeks' use in an eye clinic setting.
PURPOSE: To determine the concentration of latanoprost in bottles of latanoprost ophthalmic solution 0.005% after 4 or 6 weeks of use in patients in an eye clinic setting. METHODS: Patients treated with latanoprost for open-angle glaucoma or ocular hypertension were randomly assigned to refill their prescriptions either at the Doheny Eye Institute clinic or a local pharmacy. Patients who used latanoprost binocularly were asked to return bottles to the clinic after 4 weeks of use and nonrefrigerated storage, and those who used latanoprost monocularly were asked to return used bottles after 6 weeks. Patients were then interviewed to determine bottle storage information and doses missed. Latanoprost concentration in residual solution was analyzed in a masked fashion, by reversed-phase high-performance liquid chromatography (HPLC). RESULTS: In all, 110 patients were enrolled and 89 returned their bottles. Sixty-nine bottles had sufficient residual volume to conduct HPLC analysis. All patients reported that bottles were stored at room temperature (average high from 70-95 degrees F during the daytime). The mean +/- SD latanoprost concentration measured in the residual solutions was 48.31 +/- 2.31 microg/mL. Ninety-four percent of the bottles had concentrations within 90% to 110% of the labeled amount. No difference in latanoprost concentrations was found between the bottles used for 4 weeks versus those used for 6 weeks. CONCLUSIONS: In an eye clinic setting, latanoprost ophthalmic solution 0.005% remains stable after 4 or 6 weeks of patient use from the same bottle when stored at room temperature.
Aged↗
Efficacy and safety of nedocromil sodium ophthalmic solution in the treatment of seasonal allergic conjunctivitis.
To assess the efficacy and safety of twice-daily administration of nedocromil sodium 2% ophthalmic solution, we performed a multicenter study involving 140 patients with seasonal allergic conjunctivitis. Subjects had a history of seasonal allergic conjunctivitis and positive results of a skin test to ragweed. The trial coincided with the peak ragweed pollen season at five treatment centers. Patients treated with nedocromil sodium had improvements in symptoms with statistically significant reductions recorded for eye itching (P less than or equal to .04), conjunctival injection (P less than or equal to .001), and overall disease severity (P less than or equal to .001) as compared to the placebo-treated group. Adverse events were minor and transient. We concluded that nedocromil sodium 2% ophthalmic solution administered twice daily is effective in relieving major symptoms associated with seasonal allergic conjunctivitis.
Adolescent↗