A single-center, double-masked, randomized, vehicle-controlled, parallel-group study evaluating the efficacy and safety of brimonidine tartrate ophthalmic solution 0.025% used four times daily in a population of adult and geriatric subjects with ocular redness.

摘要

Purpose: Ocular redness is a common ophthalmic condition. There is a need for identifying topical medications that are safe, reduce ocular redness due to minor eye irritations, and maintain effectiveness for long periods of time. The aim of this study was to compare the efficacy and safety of brimonidine tartrate ophthalmic solution 0.025%, a low dose formulation of the highly selective ?±2-adrenegic receptor agonist, with its vehicle for treating ocular redness in adults and geriatric subjects. Methods: The study was a Phase 3 single-center, double-masked, randomized, vehicle-controlled, parallel-group study in healthy adult (a?￥ 18 years of age) and geriatric (a?￥ 65 years of age) subjects with ocular redness. Subjects (n=60) were randomized 2:1 (active: vehicle) to receive one drop of either brimonidine or the vehicle, bilaterally, four times daily, for up to four weeks. Following instillation of test compound, drop comfort was assessed immediately and again 1 and 2 minutes after instillation. Ocular redness was scored by the investigator at 1, 5, 15, 30, 60, 90, 120, 180, 240, 360 and 480 minutes after drug instillation. Subjects were then sent home with instructions to record ocular redness scores before and 2 minutes after each of the 4 daily doses. Results: Use of brimonidine tartrate 0.025% in subjects with ocular redness resulted in a significant reduction of ocular redness compared with vehicle as early as 1 minute after a single dose (treatment diff = -1.06, P0.0001) and lasted for up to 8 hours (treatment diff =-0.63, P=0.0008). Efficacy for ocular redness was also confirmed following repeated dosing with brimonidine tartrate 0.025%, as recorded in the subject diaries. No tachyphylaxis or rebound was evident based on the diary data. A total of 10 (16.7%) subjects experienced a total of 11 treatment emergent adverse events (TEAE). Four (10.0%) subjects treated with brimonidine tartrate 0.025% experienced an ocular TEAE; most were considered mild. No significant differences in drop comfort were reported between the 2 groups. Conclusions: In this study, treatment with brimonidine tartrate 0.025% was safe, well tolerated and resulted in reduction of ocular redness for up to 8 hours in adult and geriatric subjects with ocular redness.