Brimonidine Tartrate for Glaucoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests brimonidine tartrate eye drops to determine if they can reduce eye redness in people with glaucoma who already use certain pressure-lowering eye drops. The focus is on individuals who experience significant eye redness after using their current glaucoma medication. The trial seeks participants with open-angle glaucoma or ocular hypertension who have been on a specific eye drop treatment for at least a month and have noticeable redness. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, allowing researchers to understand how it benefits more patients.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any other topical eye medications, but you must continue using netarsudil 0.02%/latanoprost 0.005% as part of the trial.
What is the safety track record for brimonidine tartrate?
A previous study found no safety concerns for brimonidine tartrate 0.025% during eye exams. This treatment, known as Lumify, is already approved to reduce eye redness. Research has shown it doesn't significantly change eye pressure, which benefits people with glaucoma. Brimonidine tartrate has been used in higher doses for other eye conditions without major safety issues, suggesting that the lower 0.025% concentration should also be safe.12345
Why are researchers enthusiastic about this study treatment?
Brimonidine Tartrate is unique because it offers a low-concentration formulation specifically designed to reduce hyperemia, or eye redness, which is a common side effect of many glaucoma treatments. While most treatments for glaucoma, such as prostaglandin analogs or beta-blockers, focus primarily on lowering intraocular pressure, Brimonidine Tartrate also addresses patient comfort by minimizing redness. This dual benefit is particularly exciting for researchers as it may improve patient satisfaction and adherence to treatment regimens.
What is the effectiveness track record for brimonidine tartrate in treating conjunctival hyperemia in glaucoma patients?
Research has shown that brimonidine tartrate 0.025% effectively reduces eye redness, also known as conjunctival hyperemia. In this trial, participants with hyperemia greater than grade 2 on the Efron scale will receive brimonidine tartrate (Lumify). Studies have found that this treatment is well-tolerated and works similarly to other products like LUMIFY. It narrows the blood vessels in the eye, making them less visible and reducing redness. Brimonidine is already approved for treating eye redness and has a good safety record. Overall, the treatment appears promising for helping patients with eye redness while managing glaucoma.23678
Are You a Good Fit for This Trial?
This trial is for patients with glaucoma who are experiencing redness in the eyes (active hyperemia) and are currently using a combination eye drop treatment of netarsudil and latanoprost to lower eye pressure.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive brimonidine tartrate 0.025% to evaluate its effect on conjunctival hyperemia
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Brimonidine Tartrate Ophthalmic 0.025%
Trial Overview
The study is testing if an additional eye drop, brimonidine tartrate at a low dose of 0.025%, can reduce the redness in the eyes that some patients experience when they use netarsudil/latanoprost drops for their glaucoma.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients experiencing hyperemia greater than grade 2 on Efron scale will receive brimonidine tartrate (Lumify). Photo documentation of hyperemia and patient satisfaction questionnaires will be administered.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,
Lead Sponsor
Citations
A Multicenter Randomized Double-Masked Study ...
This randomized, active-controlled, multicenter study aimed to establish non-inferior efficacy of BTOS-PF 0.025% to LUMIFY 0.025% and compare ...
The Effect of Lumify™ on Ocular Redness, Intraocular ...
The purpose of this study is to evaluate the effect of Lumify™ on eye redness, intraocular pressure, and eyelid position in patients with glaucoma who are ...
3.
optometrytimes.com
optometrytimes.com/view/phase-3-study-assessing-lumify-preservative-free-and-lumify-eye-drops-meets-primary-end-pointPhase 3 study assessing LUMIFY Preservative Free and ...
“The results show that LUMIFY Preservative Free is a well-tolerated alternative option for consumers with ocular redness who have sensitivities ...
4.
ophthalmologyadvisor.com
ophthalmologyadvisor.com/news/preservative-free-brimonidine-tartrate-noninferior-to-bak-containing-formulation/Preservative-Free Brimonidine Tartrate Noninferior to BAK- ...
“BTOS-PF 0.025% demonstrated comparable efficacy and a similar safety profile to LUMIFY 0.025%, supporting its potential as a preservative-free ...
Full article: Real-world safety data for brimonidine tartrate
Additionally, brimonidine can reduce pupil size and has demonstrated clinical utilization for patients with a history of refractive surgery who ...
Low‐dose brimonidine for relief of ocular redness
No safety concerns were identified on ophthalmic examination, and there were no substantial effects on intraocular pressure. Systemic exposure ...
208144Orig1s000 | FDA
The Integrated Summary of Safety data is based on the 426 subjects on drug and 209 on placebo enrolled in a total four clinical trials. Study 11 ...
A Multicenter Randomized Double-Masked Study ...
Brimonidine tartrate ophthalmic solution 0.025% (LUMIFY® 0.025%) is the first α2-AR-selective agonist approved for ocular redness.
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