Evaluation of Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution, 0.025% for Treatment of Ocular Redness

ABSTRACT

Purpose/Aims: This study assessed the efficacy and safety of brimonidine tartrate ophthalmic solution, 0.025% for treating ocular redness in adult subjects.

Materials and Methods: This was a single-center, double-masked, randomized, vehicle-controlled, parallel-group study in subjects ≥40 years, with ocular redness. Subjects were randomized 2:1 to brimonidine or vehicle, instilled QID for four weeks. Subjects completed four visits, the last occurring one week after treatment discontinuation. The investigator assessed ocular redness on a scale of 0–4 pre-instillation and 5–240 minutes post-instillation on Day 0, pre-instillation and 5 minutes post-instillation on Days 14 and 28, and on Day35; subjects assessed redness in diaries throughout the 28-day treatment period and following treatment discontinuation. Safety assessments included adverse events (AEs), rebound redness on treatment discontinuation, comprehensive ophthalmic exams, and vital signs. Drop comfort was assessed upon instillation, and 30 seconds and 1 minute post-instillation at Day 0.

Results: Fifty-seven subjects (brimonidine, n = 38; vehicle, n = 19) were randomized. Investigator-assessed ocular redness was significantly reduced with brimonidine across the entire post-instillation time period (overall treatment difference: −1.37; P < 0.0001) and at all individual time points (P < 0.0001). Subject-assessed ocular redness was also significantly lower with brimonidine (P ≤ 0.0005). No tachyphylaxis was evident. There were few ocular AEs, all mild to moderate in severity, and no redness rebound was observed upon brimonidine discontinuation. There were no effects on any safety measures, and both brimonidine and its vehicle were reported to be very comfortable.

Conclusions: Brimonidine 0.025% appeared safe, well tolerated, and reduced ocular redness for at least 4 hours. No tachyphylaxis or rebound redness upon treatment discontinuation was observed.

KEYWORDS:

• Conjunctival hyperemia
• ocular redness
• brimonidine
• alpha-adrenergic agonist
• vasoconstrictor

Acknowledgments

Joseph B. Ciolino, MD, served as Medical Monitor for the study. Medical writing assistance was provided by Ora, Inc. This study was sponsored by Eye Therapies, Inc. The Sponsor and Ora, Inc. participated in the design of the studies and analysis of the data. Ora, Inc. supported the conduct of the trial. Gail L. Torkildsen was the study principal investigator at the single center of Andover Eye Associates. Following the completion of this study, brimonidine 0.025% ophthalmic solution was licensed to Bausch & Lomb, Inc. Bausch & Lomb, Inc. participated in the analysis of the data and approval of the manuscript.

Declaration of interest

P Gomes is the vice president of Allergy and an employee at Ora, Inc., an organization that consults and conducts research and clinical trials in the field of ocular allergy and other areas of ophthalmology and allergic diseases. CM Sanfilippo and HH DeCory are employees of Bausch & Lomb, Inc. G Torkildsen is a study investigator; she has received consultancy fees from Ora, Inc., reimbursement of meeting traveling expenses from Alcon Research Ltd., and research grants from Allergan. The authors report no other conflicts of interest in this work. The authors alone are responsible for the content and writing of the article.