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

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

publication date

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.

Testimonials

Such a nice optician. My grandson is only 4 and needs glasses. We were so sad, but he explained the issues, and we will follow up as he suggested.

Anna P.

I had such a good experience with the clinic. Very friendly staff and doctor, did not have to wait for long to be called, and was treated respectfully. Thanks, American Family.

June S.

Dr. Zurcher has gone above and beyond what any other eye doctor has ever done to figure out what is going on with my eyes. Very happy with American Family Vision.

Christine R.

Family Vision Clinic changed our lives! My daughter was frequently car sick, and she was getting headaches every day, often painful enough that they brought her to tears. We saw a string of doctors and therapists, but we made no progress. Finally, we found Dr. Levi Zurcher and his eye therapist Rain. After ten weeks of eye therapy my daughter no longer gets headaches, and she no longer gets car sick. Daily tears are a thing of the past. I really can’t say enough about this clinic. It was fascinating to watch Dr. Zurcher work. For the first time, someone who knew what they were doing was intently studying my daughter, really trying to figure out all of her eye issues, and his therapist Rain is one of the most patient and lovely people that I’ve ever had the good fortune to meet. We’re finished with eye therapy—yay!—and I have switched to American Family Vision Clinic for all of my family’s other eye health needs.

Lars Wulff

Very professional, yet kind and helpful. They do what they can to make the appointment comfortable. I was running a bit late, I made sure ti call. They were able to switch me with a patient who was already there, they treated me with respect, and helped my son have confidence by getting him the eye care he needed that day. Thank you so much! Would recommend to anyone. It's a blessing that they care enough to work with people who have all different types of insurance from work to state coverage.