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PubMed1979

[Efficacy and safety of long-term maintenance treatment with timolol ophthalmic solution in chronic open-angle glaucoma (author's transl)].

Timoptol Ophthalmic Solution (timolol maleate, MSD) is a topical beta-adrenergic receptor blokking agent which lowers elevated intraocular pressure when applied once or twice daily. It represents a major advance in topical therapy for glaucoma and elevated intraocular pressure. It is more effective in reducing elevated intraocular pressure and produces fewer side effects than pilocarpine and epinephrine. It does not alter pupil size or affect visual acuity. Timoptol maintained satisfactory reductions in intraocular pressure in long-term maintenance studies treating over 100 patients for up to 16 months. The drug was well tolerated and without serious adverse effects. In general, reductions in intraocular pressure for non-white patients (predominantly Blacks) were similar to the Whites.

Aphakia, Postcataract↗

PubMed2003

Supplementation of fexofenadine therapy with nedocromil sodium 2% ophthalmic solution to treat ocular symptoms of seasonal allergic conjunctivitis.

PURPOSE: Ocular symptoms are often under-treated in patients with allergic rhinoconjunctivitis. The efficacy of fexofenadine hydrochloride 60 mg capsules supplemented with nedocromil sodium 2% ophthalmic solution was evaluated to determine the optimal drug regimen for control of ocular allergic symptoms. METHODS: In this 5-week, open-label, randomized, multicentre comparative study, 89 patients with documented ragweed pollen allergy received fexofenadine b.i.d. with nedocromil rescue, fexofenadine q.d. with nedocromil b.i.d., or fexofenadine rescue with nedocromil b.i.d. during the ragweed pollen season. RESULTS: For all regimens, mean symptom severity scores for itching, burning, tearing, redness, grittiness, discharge, light sensitivity and swelling improved significantly (P < 0.003). Similarly, all groups experienced significant (P < 0.02) improvement in all clinical signs: erythema, oedema, discharge, conjunctival injection and conjunctivitis, as well as quality-of-life scores (P < 0.0001). All regimens reduced overall symptom severity scores after 5 min (P < 0.05) with relief persisting over 12 h (P < 0.03). Improvements in mean symptoms, signs and quality-of-life scores were similar among the treatment groups as were onset and duration of action even though patients in two of the three study arms were taking one-half or less of the recommended fexofenadine dosage. Patients and physicians judged the regimens containing lower fexofenadine dosages (with nedocromil b.i.d.) to be more effective overall than the regimen containing the highest fexo-fenadine dosage (with nedocromil as rescue only). CONCLUSIONS: Supplementation of oral fexofenadine therapy with nedocromil sodium 2% ophthalmic solution relieves ocular symptoms of seasonal allergic rhinoconjunctivitis, allowing control of rhinal symptoms with half the recommended dosage of fexofenadine.

Adolescent↗

PubMed2004

A 12-month, multicenter, randomized, double-masked, parallel-group comparison of timolol-LA once daily and timolol maleate ophthalmic solution twice daily in the treatment of adults with glaucoma or ocular hypertension.

BACKGROUND: Timolol maleate, a nonselective beta-adrenoceptor antagonist applied topically to the eye as a solution, is well known for its ocular hypotensive efficacy. A gellan formulation of timolol maleate is given once daily and has been shown to be as effective as timolol maleate solution, but is associated with ocular symptoms that may limit its utility. A new timolol maleate solution has been formulated that contains potassium sorbate (timolol-LA [TLA; Istalol(R)]) to enhance the ocular bioavailability of timolol instilled into the eye, as well as half the benzalkonium chloride preservative found in timolol maleate. OBJECTIVE: The objective of this trial was to assess the ocular hypotensive efficacy and safety profile of TLA 0.5% solution once daily with those of timolol maleate ophthalmic solution (TIM) 0.5% twice daily in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: This multicenter, prospective, randomized, double-masked, parallel-group clinical trial was conducted at 21 participating private practices across the United States. Patients aged > or =18 years with OAG or OHT in 1 or both eyes and an unmedicated intraocular pressure (IOP) of > or =22 mm Hg were randomized to receive either TLA once daily or TIM twice daily bilaterally for 12 months. The primary outcome measure was IOP (95% CIs) on treatment difference at each visit (ie, equivalence analysis). The safety profile was assessed based on biomicroscopic and ophthalmoscopic examination and patient symptoms. RESULTS: A total of 332 patients (203 women, 129 men; mean [SEM] age, 64.6 [11.8] years [range, 29-92 years]) entered the study. Of these, 290 patients (87.3%) completed it. At none of the visits did the 95% CIs for between-treatment comparisons exceed 1.5 mm Hg and, at most of the visits, these intervals did not exceed 1.0 mm Hg. Mean baseline IOP was approximately 25 mm Hg in both groups. IOP was reduced at all posttreatment visits to 18 to 19 mm Hg at peak and to approximately 19 to 20 mm Hg at trough drug level in both treatment groups. Mean reductions from baseline were 6 to 7 mm Hg at peak and 5 to 6 mm Hg at trough (25.5%-28.7% and 20.8%-24.7%, respectively). Seventeen patients (5.1%) withdrew due to adverse events (AEs) (10 patients [6.0%] and 7 patients [4.2%] in the TLA and TIM groups, respectively). Based on biomicroscopic and ophthalmoscopic examination and volunteered symptoms, the safety profile was similar between the 2 treatments, except for burning and stinging on instillation, with an incidence of 41.6% in the TLA group and 22.9% in the TIM group (P = 0.001). Nearly all cases of burning and stinging were mild (94.2% [65 events] with TLA and 90.0% [36 events] with TIM), and none of the patients discontinued treatment due to this AE. CONCLUSIONS: TLA solution, a nonselective beta-adrenoceptor antagonist, given once daily in the morning, was found to be statistically equivalent in ocular hypotensive efficacy (as defined a priori) compared with TIM, given twice daily, and with an acceptable safety profile in this study population of adult patients.

Adult↗

PubMed2003

Efficacy of ketotifen fumarate 0.025% ophthalmic solution compared with placebo in the conjunctival allergen challenge model.

BACKGROUND: Ketotifen fumarate blocks histamine1 (H1) receptors, stabilizes mast cells, and acts as an eosinophil inhibitor (decreases chemotaxis and activation of eosinophils). OBJECTIVE: To assess the efficacy of ketotifen 0.025% ophthalmic solution in the prevention of symptoms of allergic conjunctivitis, using the conjunctival allergen challenge model. METHODS: This was a single-center, double-masked, randomized, placebo-controlled, contralateral-eye comparison, allergen challenge trial conducted in the United States. Subjects were randomized to receive ketotifen 0.025% in one eye and placebo in the other. At visits 1 and 2, allergen challenges were performed to determine the allergen concentration eliciting a qualifying reaction for each subject. At the 3 subsequent visits, subjects received 1 drop of ketotifen 0.025% ophthalmic solution in one eye and vehicle solution as placebo in the other eye 15 minutes (visit 3), 6 hours (visit 4), and 8 hours (visit 5) before allergen challenge. The primary efficacy measure was the subject's rating of itching at 3, 7, and 10 minutes after challenge. RESULTS: Of the 89 subjects randomly assigned to masked trial medication at visit 3, 72 completed the study. At visits 3, 4, and 5, mean itching scores were significantly better for ketotifen-treated eyes at all postchallenge time points, compared with placebo (P<.001). Also at visits 3, 4, and 5, ketotifen was statistically superior to placebo in reducing ocular hyperemia at all postchallenge time points (P<.05). CONCLUSIONS: Ketotifen was safe and statistically effective in reducing ocular itching and hyperemia associated with allergic conjunctivitis. Ketotifen's rapid onset of action (within 15 minutes) and extended duration of action (at least 8 hours) make it a valuable treatment for allergic conjunctivitis.

Adult↗

PubMed2004

Clinical evaluation of ophthalmic lomefloxacin 0.3% in comparison with fortified cefazolin and gentamicin ophthalmic solutions in the treatment of presumed bacterial keratitis.

OBJECTIVE: To evaluate the efficacy and safety of 0.3% lomefloxacin single agent solution, by comparing to a combination of fortified ophthalmic solutions of cefazolin sodium 50 mg/ml and gentamicin sulfate 14 mg/ml, in the treatment of acute bacterial keratitis. DESIGN: Prospective, double-masked, randomized comparative trial. METHOD: Forty patients with clinical diagnosis of any grade of severity of acute bacterial keratitis were randomized into 2 treatment groups: 20 to fortified cefazolin-gentamicin group, and 20 to lomefloxacin-normal saline group. The dosing of the drugs were scheduled for both treatment groups as follows: 1 drop of each solution was alternately instilled every 5 minutes for the first 30 minutes (as loading dose), then 1 drop with 5-minute interval between 2 bottles instilled hourly for day 1-3, tapering to every 2 hours on day 4-6, and every 4 hours on day 7-14. After day 14, dosing discretion was clinically adjusted, based on the clinical condition and finally discontinued after complete healing. Corneal scraping for cultures was obtained before starting the treatment. Ocular symptoms and signs, time to heal and adverse reactions were evaluated and compared between the 2 groups on day 2, 4, 7, 14, 21 and 28. RESULTS: No clinically or statistically significant difference were noted between two treatment groups, regarding demographic, symptoms and signs associated with bacterial keratitis. Positive results of bacterial corneal cultures were obtained in 27.5%. There was no statistically significant difference in time to complete re-epithelialization in all types of bacterial keratitis (P=0.251). By day 7, the keratitis was healed: 44% in lomefloxacin group, and 33% in fortified antibiotic group. Both study medications were well-tolerated, with no incidence of reported adverse event. CONCLUSION: In this study, eventhough there is no statistically significant difference of symptoms and signs between the two study groups at any study visit, we found clinical improvement in all patients in lomefloxacin group. So, lomefloxacin may be used as an alternative to standard treatment in acute bacterial keratitis.

Acute Disease↗

PubMed2004

Effect of brimonidine tartrate 0.2% ophthalmic solution on pupil size.

PURPOSE: To evaluate the effect of brimonidine tartrate 0.2% ophthalmic solution on pupil size under scotopic and photopic luminance conditions in persons considering laser refractive surgery. SETTING: Ophthalmic Health Center, Tel Aviv, Israel. METHODS: The pupil size was measured in 36 eyes of 36 participants under scotopic and photopic conditions using the Colvard pupillometer (Oasis Medical) before and after brimonidine tartrate drops were administered. The pupil size was subsequently measured after 30 minutes and 4 and 6 hours. RESULTS: No difference was found in pupil size before brimonidine tartrate instillation in eyes with light or dark irides. Before instillation, the mean photopic pupil size was 4.81 mm +/- 0.54 (SD) (range 4.0 to 6.0 mm). At 30 minutes, all pupils became miotic, with a mean size of 3.77 +/- 0.51 mm (range 3.0 to 5.0 mm) (P<.0001). After 6 hours, 27.8% of the pupils had returned to their previous size. Before brimonidine tartrate administration, the mean scotopic pupil size was 6.22 +/- 0.73 mm (range 5.0 to 8.0 mm). There was significant miosis to 4.57 +/- 0.84 mm (range 3.0 to 6.5 mm) (P<.0001) that continued for at least 6 hours. The miotic effect of brimonidine tartrate was stronger in eyes with light irides. CONCLUSIONS: Brimonidine tartrate caused significant miosis, especially under scotopic conditions, most likely from its alpha-2 adrenergic effect. Under photopic luminance conditions, the miotic effect was pronounced.

Adrenergic alpha-Agonists↗

PubMed2004

pH stability of ophthalmic solutions.

BACKGROUND: In this study, we evaluated the pH value of 17 ophthalmic solutions, and we investigated whether the pH of these solutions changed over time after the bottle was opened. METHODS: Fifteen bottles of each type of solution were chosen at random from different production lots. A 0.05-ml increment was taken from each bottle and was measured daily using a micropH 2002 Crison pH-meter over a period of 30 days. RESULTS: The results revealed differences between the pH values of the solutions; nine solutions presented pH values within ocular comfort range and eight solutions presented pH values between 3.5 and 6.4. Ten solutions presented nonstatistically significant variations over time (p > 0.01) and seven solutions presented isolated but statistically significant variations. CONCLUSIONS: We may assume that the nine solutions with pH values within the ocular comfort range will not produce initial discomfort. The solutions with acid pH values will produce initial discomfort. The solutions with nonstatistically significant pH variations over 30 days in relation to their initial pH values presented great stability.

Drug Stability↗

PubMed2001

Ocular safety of INS365 ophthalmic solution: a P2Y(2) agonist in healthy subjects.

The purpose of this study was to evaluate the ocular safety and tolerability of the P2Y(2) receptor agonist, INS365, when applied as eye drops in normal human subjects. This study was a double-masked, placebo-controlled, randomized, within subject paired-comparison, dose-escalation study in five cohorts of ten healthy subjects. The concentrations of INS365 ophthalmic solution were 0.5, 1.0, 2.0, and 5.0% given three times over six hours. Safety was assessed by general and ophthalmic examination and symptomatology. Unanesthetized Schirmer tests were performed in the last cohort of 10 subjects to evaluate the acute effects of INS365 on tear secretion. There were no significant differences in the number of subjects with ocular events reported in placebo-treated eyes compared to INS365-treated eyes. Two adverse events were possibly related to INS365: painless blepharospasm and an increase in lacrimation after 5.0% INS365 instillation. Unanesthetized Schirmer testing showed no acute effects of INS365 on tear secretion, compared to its vehicle, in healthy subjects, in which reflex tearing often produced maximal Schirmer values. INS365 ophthalmic solution was well-tolerated when administered by ocular instillation. Stimulation of ocular surface P2Y(2) receptors was not associated with ocular tolerability issues in healthy subjects.

Administration, Topical↗

PubMed2005

Simultaneous determination of active ingredients in an ophthalmic solution by isocratic tandem-mode HPLC connected reverse phase column and strong cation exchange column.

A tandem-mode high performance liquid chromatography (HPLC) system is described here, which employs reversed phase liquid chromatography (RPLC) followed by strong cation exchange liquid chromatography (SCX), was used to determine the mixture of six ingredients in an ophthalmic solution. As a result of investigations, isocratic HPLC methods that using two columns in tandem-mode; Atlantis dC18 (75 mm x 4.6 mm i.d., 3 microm, ODS) and CAPCELL PAK SCX UG80 (75 mm x 4.6 mm i.d., SCX), which have different separation modes, and control of mixture of methanol/ammonium dihydrogenphosphate buffer as used for the eluent, allowed for six target ingredients to be determined simultaneously. And all ingredients separated perfectly and were determined efficiently and rapidly. Validation of the method was accomplished with respect to linearity (r>0.999), recovery (99.4-100.4%), precision (R.S.D. 0.1-0.9%) and specificity. These results suggest that the fusion of different separation modes can be used for the simultaneous determination of ingredients in ophthalmic solutions, and this can be accomplished rapidly and with high precision.

Aminocaproic Acid↗

PubMed2005

The fixed combination of fortified vancomycin and amikacin ophthalmic solution--VA solution: in vitro study of the potency and stability.

PURPOSE: We compared the in vitro potency and stability of a fixed combination of vancomycin and amikacin solution (VA solution) with amikacin or vancomycin solution. METHODS: Solutions of 2% amikacin (20 mg/mL) and of 5% vancomycin (50 mg/mL) and VA solution (each 1 mL contained 20 mg of amikacin and 50 mg of vancomycin) were prepared from parenteral antibiotics by reconstituting them with sterile injection water and refrigerated (4 degrees C) in the dark. Triplicate 5-mL portions of each solution were tested before storage and 7 and 14 days after preparation for potency of antimicrobial activity by the disk diffusion method and for stability. RESULTS: There were no significant differences in the diameter of zones of inhibition of VA solution compared with amikacin or vancomycin solution within a 2-week period. Visual inspection revealed that all solutions remained clear, colorless, and particle-free at 4 degrees C throughout the study period. For osmolarity, the VA solution was much higher than that of either amikacin or vancomycin solution at all tested times and more near the well-tolerated range of human eyes. There were no significant differences at days 0, 7, or 14 for either vancomycin, amikacin, or VA solution. For pH, the VA solution was higher than that of vancomycin solution (nearly equal to that of amikacin solution) at each time and more near the level of normal tear film. The pH did not differ significantly for either vancomycin, amikacin, or VA solution at all tested times. CONCLUSIONS: The vancomycin and amikacin ophthalmic solutions can be mixed together with the same potency and stable physical properties. It may be useful in the treatment of bacterial keratitis pending clinical trials to determine its effectiveness and safety.

Amikacin↗

PubMed2004

Effects of travoprost 0.004% ophthalmic solution, six weeks after its laminated packaging had been removed, in primary open-angle glaucoma: a randomized, controlled, investigator-blinded study.

BACKGROUND: Primary open-angle glaucoma (POAG) is a chronic and progressive optic nerve and retinal nerve fiber layer neuropathy, with characteristic visual field damage. The intraocular pressure (IOP) is typically higher than the level considered statistically normal. Although there is no known cure, appropriate reduction of IOP with hypotensive drugs (eg, the topical prostaglandin analogue travoprost) delays the progression of POAG. Chemical-stability studies of travoprost performed by the manufacturer suggest that the stability of travoprost is maintained beyond the expiration date, which is 6 weeks after the laminated packaging has been opened. OBJECTIVE: The goal of this study was to assess the efficacy and tolerability of travoprost 0.004% ophthalmic solution, 6 to 12 weeks after its expiration date, in patients with POAG. METHODS: This randomized, controlled, investigator-blinded study was conducted at 2 centers in Brazil: the Ophthalmology Department, Federal University of Goiás, Goiânia, and the Ophthalmology Department, Santa Casa de Misericordia Hospital in São José do Rio Preto, Sao Paulo. Patients with POAG (in 1 or both eyes) were randomly assigned to receive travoprost, either from a bottle from which the laminated packaging had been removed and that had been stored at room light and temperature for 6 weeks (ie, after the expiration date; opened group), or from a bottle that had been sealed until first use by the patient (control group). Drug was to be administered, 1 drop in the lower conjunctival sac (in the affected eye[s]), QD between 7 pm and 9 pm, for 6 weeks. IOP was measured at study weeks 0 (baseline), 4, and 6. The 2 treatment groups were compared with regard to hypotensor effect and incidence of adverse events (AEs). RESULTS: : Thirty-one patients completed the study (55 eyes; 28 right and 27 left eyes; 35 eyes of women, 20 eyes of men). The mean (SD) ages of the opened and control groups were 61.8 (13.5) and 62.8 (14.1) years, respectively. Twenty-four patients were included in both treatment groups (ie, 1 eye per group). The baseline IOP was similar between the 2 treatment groups. There was a significant reduction in IOP in both groups at 4 and 6 weeks (both, P < 0.001 vs baseline). However, no significant differences in IOP were found between the 2 treatment groups at any time during the study. Conjunctive hyperemia and a burning sensation in the eye immediately after application were the only AEs reported; the incidence of these was similar between the 2 treatment groups. CONCLUSIONS: In this study of patients with POAG, IOPs and AEs were similar in eyes receiving 6 weeks of treatment with travoprost 0.004% ophthalmic solution, either from bottles from which the laminated packaging had been opened and that had been stored at room light and temperature for 6 weeks (ie, after the expiration date), or from bottles that had been sealed until first use by the patient. These results suggest that travoprost remains effective for at least 12 weeks after the laminated packaging has been opened.

Cloprostenol↗

PubMedDate not supplied

In vitro cytotoxicity test for estimating non-ocular irritation dose of ophthalmic solutions.

The in vitro cytotoxicity test for estimating the non-ocular irritation dose of ophthalmic solutions was investigated. In the in vitro test, normal human epidermal keratinocytes (NHEK) in a confluent monolayer were incubated for 48 hr in a medium with test compounds. The concentration of a test compound which causes a 50% reduction in NHEK viability was determined as IC50 by MTT colorimetric assay. For comparison, the in vivo rabbit ocular irritation tests were carried out by the standard Draize method. The maximum concentration, which did not show any ocular irritation, was determined as DS0. The results showed the correlation coefficient between the IC50 values and the DS0 values for 19 test compounds to be 0.82. However, the correlation coefficients for 10 compounds, which have IC50 values of less than 300 micrograms/ml, and for 7 alcohols were 0.99. The IC50-DS0 correlation curves obtained could be utilized as the critical concentrations for ocular irritation. These results suggest that our in vitro/in vivo test can estimate non-ocular irritation dose of the ophthalmic preparations in advance of the in vivo tests.

Animals↗

PubMed1987

Effectiveness of ketorolac tromethamine 0.5% ophthalmic solution for chronic aphakic and pseudophakic cystoid macular edema.

The effect of ketorolac tromethamine 0.5% ophthalmic solution (a new nonsteroidal anti-inflammatory agent) treatment was compared to placebo treatment in patients with chronic, angiographically proven aphakic or pseudophakic cystoid macular edema (visual acuity less than or equal to 20/40 for six months) during a three- to four-month double-masked, randomized study. Twenty-six patients completed this study without significant ocular or systemic toxicity. The improved distance visual acuity observed in the ketorolac treatment group (8/13 patients) was statistically different from the improved vision observed in the placebo treated group (1/13 patients) (P = .005). No patient on a regimen of ketorolac therapy had a significant decrease in Snellen distance visual acuity while on treatment, but two patients in the placebo group demonstrated a decrease in visual acuity of two lines or more. Fluorescein angiography was consistent with changes in visual acuity.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed1992

Effects of timolol ophthalmic solution on the intra-ocular pressure rise induced by suxamethonium and tracheal intubation.

Thirty patients received topical application of either timolol ophthalmic solution 0.25%, or normal saline, 2 h before elective ophthalmic surgery in a double-blind study. The responses to suxamethonium and tracheal intubation were compared by measuring intra-ocular pressure before induction of anaesthesia, 1 min after administration of thiopentone 2-4 mg.kg-1, 1 min after administration of suxamethonium 1 mg.kg-1, and 1, 2.5 and 5 min after tracheal intubation. There was no significant difference between the groups.

Adult↗

PubMed1994

Evaluation of nedocromil sodium 2% ophthalmic solution for the treatment of seasonal allergic conjunctivitis.

During peak ragweed season, 86 patients with seasonal allergic conjunctivitis participated in a 9-week, multicenter, double-masked, placebo-controlled, group-comparative study testing the efficacy and safety of bid nedocromil sodium, 2% ophthalmic solution. The clinical effectiveness of nedocromil sodium was measured by analyzing the means of patient daily symptom scores and eye examinations after 1, 3, 5, and 8 weeks of treatment. The use of nedocromil sodium during peak ragweed pollen season reduced symptom scores with statistically significant treatment differences as compared with the placebo for itchy eyes, tearing, overall eye condition, and symptom summary score. Clinician assessments also favored the use of nedocromil sodium as indicated by significant improvements in tearing, conjunctival injection, and conjunctival edema. No significant side effects were reported by the patients, allergists, or ophthalmologists. We conclude that nedocromil sodium, 2% ophthalmic solution, administered bid is more effective in the relief of symptoms of seasonal allergic conjunctivitis than placebo and causes no major side effects.

Adolescent↗

PubMedDate not supplied

Daily cost of ophthalmic solutions for treating glaucoma in Japan.

PURPOSE: We conducted a study of the daily cost of various ophthalmic solutions used in Japan for treating glaucoma: beta-adrenergic blockers (11 products), epinephrine (3), cholinergics (3), prostaglandins (2), and carbonic anhydrase inhibitors (2). METHODS: The total number of drops in one bottle of each solution was counted drop by drop. The cost per drop was calculated by dividing the government-controlled standard prices by the total number of drops in one bottle. The daily cost of therapy was calculated by multiplying the cost per drop by the number of drops typically used per day. RESULTS: The average cost of each preparation was calculated based on the prices and the daily usage. The daily cost of the beta-adrenergic blockers studied ranged widely, from $0.43 to $1.04. CONCLUSIONS: These data may be useful in selecting ophthalmic products for glaucoma therapy in Japan.

Adrenergic Agonists↗

PubMed1995

Safety and efficacy of diclofenac sodium 0.1% ophthalmic solution in acute seasonal allergic conjunctivitis.

A randomized clinical trial was conducted to compare diclofenac sodium 0.1% ophthalmic solution to placebo in relieving ocular signs and symptoms in patients with acute seasonal allergic conjunctivitis. Twenty patients (10 per treatment) qualified for this two week, double-masked study with moderate itching, bulbar conjunctival injection and a positive skin test. Diclofenac was statistically and clinically superior in the physician's global evaluation (p = 0.03) and the primary composite score [itching + bulbar/palpebral conjunctival injection (p = 0.037)] after two weeks of treatment. Four patients experienced some transient ocular burning/stinging with diclofenac. Diclofenac sodium appears to be effective for relieving the ocular signs and symptoms associated with acute seasonal allergic conjunctivitis.

Acute Disease↗

PubMedDate not supplied

Safety of unoprostone isopropyl 0.15% ophthalmic solution in patients with mild to moderate asthma.

PURPOSE: To assess the safety of unoprostone isopropyl 0.15% ophthalmic solution (UIOS) in patients with mild to moderate asthma. METHODS: Randomized, double-masked, two-period crossover, placebo-controlled study comparing unoprostone 0.15% with vehicle-placebo. Pulmonary function tests conducted at baseline and during the 4-hour postdose observation period included forced expiratory volume in 1 s, forced vital capacity, peak expiratory flow rate, and bronchodilator response after 200 microg inhaled salbutamol. RESULTS: There were no significant changes in pulmonary function up to 4 h postdose after treatment with 1 drop unoprostone 0.15% in each eye. CONCLUSION: Unoprostone 0.15% was safe for use in patients with mild to moderate asthma, without affecting the response to bronchodilator therapy.

Administration, Inhalation↗