Authors
McLaurin, Eugene MD; Cavet, Megan E. PhD; Gomes, Paul J. MS; Ciolino, Joseph B. MD

Brimonidine Ophthalmic Solution 0.025% for Reduction of Ocular Redness: A Randomized Clinical Trial

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Abstract/Introduction

SIGNIFICANCE 

The α2-adrenergic receptor agonist brimonidine has been reported to induce conjunctival blanching in cataract, strabismus, laser refractive, and filtration procedures. Clinicians are often faced with red eyes with no apparent underlying pathology. Low-dose brimonidine reduced ocular redness in such subjects with efficacy maintained over 1 month and negligible rebound redness.

PURPOSE 

The aim of this study was to evaluate the safety and efficacy of brimonidine tartrate ophthalmic solution 0.025% for the treatment of ocular redness.

METHODS 

In this single-center, double-masked, phase 3 clinical trial, adult subjects with baseline redness of more than 1 unit in both eyes (0- to 4-unit scale) were randomized 2:1 to brimonidine 0.025% or vehicle. A single dose was administered in-office (day 1); thereafter subjects instilled treatment four times a day for 4 weeks, with clinic visits on days 15, 29, and 36 (7 days post-treatment). Efficacy end points included investigator-evaluated redness 5 to 240 minutes post-instillation on day 1 (primary); investigator-evaluated change from baseline 1, 360, and 480 minutes post-instillation on day 1, and 1 and 5 minutes post-instillation on days 15 and 29; total clearance of redness, and subject-assessed redness. Safety/tolerability measures included adverse events, rebound redness, and drop comfort.


Conclusion/Results

RESULTS 

Sixty subjects were randomized (n = 40 brimonidine, n = 20 vehicle). Investigator-assessed redness was lower with brimonidine versus vehicle over the 5- to 240-minute post-instillation period (mean [SE], 0.62 [0.076] vs. 1.49 [0.108]; P < .0001) and at each time point within that period (P < .0001). At 1, 360, and 480 minutes post-instillation, respectively, the mean differences (95% confidence interval) between treatments were −0.73 (−1.05 to −0.41), −0.57 (−0.84 to −0.29), and −0.39 (−0.67 to −0.10), respectively. No tachyphylaxis was evident with brimonidine on days 15 and 29, and minimal rebound redness was observed following discontinuation. Adverse events were infrequent, and brimonidine was rated as very comfortable.

CONCLUSIONS 

Brimonidine 0.025% appeared safe and effective for reduction of ocular redness, with an 8-hour duration of action, no evidence of tachyphylaxis, and negligible rebound redness.


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Testimonials


My eight year old daughter was terrified to go to the eye doctor for fear of her eyes being dilated. The doctor was SO KID friendly! He immediately made her comfortable by engaging her in conversation. It was a geat experience.


Joya B.

Dr. Garbus spent an amazing amount of time to solve my very complicated visual problems. Over the years he has continually achieved results beyond what others felt possible. He is always up to date on the latest science. He is great!


Dolores K.

Family Vision Care Valencia makes it so easy. Staff is knows what they are doing and Dr. Garbus is thorough and kept me well informed during the exam.


Kristy B.

I have been coming to Family Vision Center for almost 20 years. Dr. Garbus has been able to help my vision when other doctors could not. Now my kids see him as well. I highly recommend this office!


Autumn C.

The Doctor is very good. I felt on this visit he seemed rushed. I had questions to ask him but he was already with another patient. I still do not know if my eyes are the same , worse, or better.


Howard B.

All the staff is friendly, helpful and knowledgeable, and has been for all the years I have been going there.


Mary Ann H.
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