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Gerald Horn, Matt Chapin, Paul Gomes; A Parallel-Group Study Evaluating the Safety and Efficacy of BrimonidineTartrate 0.025% Ophthalmic Solution in a Population of Adult and Geriatric Subjects. Invest. Ophthalmol. Vis. Sci. 2013;54(15):5451.
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Vasoconstrictors are currently the most widely used ophthalmic drop. Longer lasting, more effective agents with improved safety and reduced rebound are needed.
This study employed a single-center, double-masked, randomized, vehicle - controlled, parallel-group design to evaluate the safety and efficacy of brimonidine tartrate 0.025% ophthalmic solution versus vehicle in a population (N=57) of adult (> 40 years of age) and geriatric (> 65 years of age) subjects dosed QID for 4 weeks. Subjects were randomized without age stratification to receive either brimonidine or vehicle. Following instillation of test compound, subjects scored the drop for comfort (0-10 scale) immediately, and again 1 and 2 minutes after instillation. Ocular redness was then scored by the investigator at 5, 15, 30, 60, 90, 120, 180, and 240 minutes after medication instillation (0-4 scale, .5 unit increments). Subjects were then sent home with instructions to record ocular redness scores before and 2 minutes after each of the 4 daily doses. In addition, they were instructed that the interval between doses should be no less than 3.5 hours. Diaries were collected after 2 weeks and again after 4 weeks.
Subjects reported a high degree of comfort with both the brimonidine drop (mean comfort 0.7±1.48 for all scores) and the vehicle (0.4±1.24). Adverse events were minimal in both groups. In the time course of redness scores recorded after the 1st instillation, the brimonidine-treated group were both clinically and statistically superior to the vehicle treated group at all time points. The differences between pre- and post-instillation readings for the brimonidine group diary scores were also significant, while those of the vehicle group were not.
Brimonidine 0.025% was effective in reducing ocular redness both in office assessments by a clinician and in subjective diary assessments. Onset of action was rapid (within 5 minutes), and the duration of action ≥ 4 hours. QID dosing of brimonidine 0.025% for 4 weeks in an adult population aged 40 years and older (including geriatrics) was tolerable and safe. The drops were very comfortable, and there is no indication of any redness rebound or drug-induced hypersensitivity issues.
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