ABSTRACT.Objective: This study was conducted to compare the efficacy and safety of olopatadine ophthalmic solution (0.1 %) with ketorolac ophthalmic solution (0.5%) in a clinical model of acute allergic conjunctivitis. Olopatadine is a dual acting H 1 histamine receptor antagonist and a mast cell stabilizer, shown to be effective in treating allergic conjunctivitis. Ketorolac is a non-steroidal anti-inflammatory drug approved in the United States for the relief of ocular itching associated with seasonal allergic conjunctivitis. Methods: The provocative antigen challenge model was used in this randomized, double-blind, single-center, crossover study. The allergen and concentration that consistently elicited a positive allergic reaction was used for challenge. After at least 14 days, subjects were randomized to receive either olopatadine in one eye and placebo in the contralateral eye, or ketorolac in one eye and placebo in the contralateral eye. Twenty-seven minutes after drug instilJation subjects were challenged with allergen. At 3, 10, and 20 minutes following allergen challenge, subjects graded ocular itching and were assessed for hyperemia in conjunctival, ciliary, and episcleral vessel beds. Approximately 14 days later, subjects received the alternate treatment in one eye and placebo in the contralateral eye. They were again challenged with allergen and their responses were rated in the same manner. Results: Olopatadine significantly (p< 0.0001) reduced both ocular itching and hyperemia in all three vessel beds compared to placebo at all time points tested following allergen challenge. Ketorolac did not significantly reduce itching and showed a trend of increased hyperemia compared to placebo. Olopatadine was significantly {p< O.OOI) more effective than ketorolac in reducing hyperemia and ocular itching at all time points and was also significantly (p< 0.05) more comfortable than ketorolac as reported by subjects immediately following drug instillation. Conclusion: The study demonstrated that olopatadine is effective and safe in preventing and treating ocular itching and hyperemia associated with acute allergic conjunctivitis and is more effective and more comfortable than ketorolac.

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BackgroundThis study was designed to evaluate the occurrence and severity of ocular hyperemia in subjects with elevated intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension (OHT) following treatment with bimatoprost 0.01% in a real-world clinical setting.MethodsThis was an open-label, observational study conducted at 67 centers in Canada. Subjects with elevated IOP due to POAG or OHT instilled bimatoprost 0.01% topically as monotherapy once daily. Ocular hyperemia was graded by the investigator at baseline and weeks 6 and 12 using a photographic five-point grading scale. Change in IOP from baseline was also evaluated at these time points. This analysis includes only the subgroup of 522 subjects who were naïve to IOP-lowering medication prior to the study.ResultsAfter 12 weeks of treatment with bimatoprost 0.01%, hyperemia was graded as none-to-mild (grades 0, +0.5, or +1) for 93.3% of subjects and as moderate-to-severe (grades +2 or +3) for 6.7%. At weeks 6 and 12, most subjects (93.2% and 93.5%) had no change in hyperemia grade from baseline. IOP was reduced by 7.4 mmHg (29.8%) at week 6 and 7.7 mmHg (30.9%) at week 12 from baseline.ConclusionThis real-world, observational study found that bimatoprost 0.01% instilled once daily reduced IOP by a mean of 30% from baseline without moderate or severe ocular hyperemia in 93% of treatment-naïve subjects with POAG or OHT.

ABSTRACT.Purpose: To compare the ocular comfort of two ophthalmic anti-allergic agents: olopatadine hydrochloride 0.1% and ketotifen fumarate 0.05%. Subjects and Methods: In a double-masked, multi-centered, randomized trial, 80 subjects were asked to make a 'forced choice' based on ocular comfort between one drop of olopatadine hydrochloride 0.1% instilled in one eye and one drop of ketotifen fumarate 0.05% instilled in the contralateral eye. At one site, the incidence of adverse reactions was also reported. Results: All subjects (100%) selected olopatadine as the more comfortable formulation. One site (nΩ35) reported a 49% incidence of moderate burning and a 49% incidence of mild burning after ketotifen instillation. One subject (2% of population) at this site experienced no ocular discomfort with ketotifen. There were no reports of discomfort associated with olopatadine instillation. Conclusion: Olopatadine is a more comfortable ophthalmic preparation than ketotifen.