Lumify for Glaucoma Side Effects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how well Lumify™ eye drops reduce redness and other side effects in people with glaucoma, a condition that damages the optic nerve and can lead to vision loss. Lumify™ is already approved to reduce eye redness, and this study will determine if it can benefit those using other glaucoma eye drops. Participants will receive either Lumify™ or a saline solution in each eye to compare results. Suitable candidates are those who have used specific glaucoma eye drops for more than six weeks and have primary open-angle glaucoma, the most common type. As a Phase 4 trial, Lumify™ is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.
Will I have to stop taking my current medications?
The trial requires that you continue using your current brimonidine eye drops, as participants must have been using them for more than 6 weeks to be eligible.
What is the safety track record for Lumify™?
Research has shown that Brimonidine Tartrate Ophthalmic Solution 0.025%, the main ingredient in Lumify, is usually well-tolerated. In clinical studies, most participants experienced only mild to moderate side effects, with the most common being eye irritation, dry mouth, and a slight burning or stinging sensation in the eyes.
More serious side effects are rare. About 1-4% of patients reported a temporary change in vision. Importantly, serious side effects like low blood pressure or heart problems, which can occur with similar drugs, did not appear with Brimonidine.
Overall, the FDA has approved Lumify for reducing eye redness, and it has a strong safety record for this use. This suggests it should be safe for managing side effects in glaucoma treatment.12345Why are researchers enthusiastic about this study treatment?
Most treatments for glaucoma aim to reduce intraocular pressure using medications like prostaglandin analogs, beta-blockers, or carbonic anhydrase inhibitors. However, Lumify™, which contains brimonidine tartrate at a 0.025% concentration, is unique because it works differently by selectively targeting alpha-2 adrenergic receptors. This mechanism can potentially reduce eye redness and pressure without the systemic side effects often associated with higher concentrations of brimonidine. Researchers are excited about Lumify™ because it offers a promising alternative for managing glaucoma's side effects with potentially fewer adverse effects and improved patient comfort.
What is the effectiveness track record for Lumify in treating eye redness associated with glaucoma?
Research shows that Brimonidine Tartrate Ophthalmic Solution 0.025%, known as Lumify™, effectively reduces eye redness. Studies indicate it manages this redness with minimal side effects, such as temporary blurry vision. While Lumify™ primarily addresses redness, researchers are exploring its potential benefits for glaucoma-related issues. In this trial, one eye of each participant will receive Lumify™, while the other eye will receive a sterile balanced saline solution as a control. Since the FDA has already approved Lumify™ for eye redness, there is confidence in its safety and initial effectiveness. Current research focuses on its impact on eye pressure and eyelid position in glaucoma patients.16789
Who Is on the Research Team?
Ze Zhang, MD
Principal Investigator
Tulane University
Are You a Good Fit for This Trial?
This trial is for adults over 18 with primary open-angle glaucoma who've been using Brimonidine eye drops (0.1%, 0.15%, or 0.2%) for more than six weeks and can consent to participate. It's not for pregnant individuals, prisoners, those with recent surgeries, lid surgery or botox history, allergies to brimonidine, or use of certain eye medications within the last week.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single drop of either Lumify™ or a sterile balanced saline solution in each eye
Follow-up
Participants are monitored for ocular redness, intraocular pressure, and eyelid position 60 minutes after application
What Are the Treatments Tested in This Trial?
Interventions
- Brimonidine Tartrate Ophthalmic Solution 0.025%
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tulane University
Lead Sponsor