Brimonidine Tartrate for Glaucoma

Overseen By Crystal Remington Optometrist, OD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,

Must be taking: Netarsudil/latanoprost

Must not be taking: Other ocular medications

Disqualifiers: Allergy, Ocular infection, Dry eyes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

35 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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

I can switch my glaucoma treatment to a specific medication for at least 4 weeks.

Have a best corrected Visual Acuity by Snellen chart of 20/30 or better in study eye

Willing and able to comply with study procedures and attend follow-up visits

Exclusion Criteria

I have moderate to severe dry eyes.

Have pterygium/pinguecula, chemosis, episcleritis, scleritis (or any condition that may affect hyperemia grading) in the opinion of the investigator

Pregnant, plan to become pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brimonidine tartrate 0.025% to evaluate its effect on conjunctival hyperemia

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Brimonidine Tartrate Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12370570/

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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04007276

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-point

Phase 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 ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/17469899.2024.2435809

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6587872/

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 ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2017/208144Orig1s000MedR.pdf

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 ...

8. link.springer.com link.springer.com/article/10.1007/s40123-025-01194-z

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.