Lumify for Glaucoma Side Effects

Recruiting in Palo Alto (17 mi)

Overseen by Ze Zhang, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Tulane University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing Lumify™ eye drops, which help reduce eye redness, in glaucoma patients who are already using Brimonidine eye drops. These patients often have red eyes as a side effect of their current treatment. Lumify™ works by making the blood vessels in the eyes smaller, which helps to reduce redness.

Research Team

Ze Zhang, MD

Principal Investigator

Tulane University

Eligibility Criteria

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

Willing and able to give informed consent

I have been diagnosed with primary open angle glaucoma.

I am older than 18 years.

Exclusion Criteria

I cannot sit comfortably for 30 minutes.

I haven't used eye whiteners or allergy drops in the last week.

I have never had eyelid surgery or Botox injections.

Treatment Details

Interventions

• Brimonidine Tartrate Ophthalmic Solution 0.025% (Alpha-2 Adrenergic Agonist)

Trial Overview The study tests Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) against a saline solution in glaucoma patients already on Brimonidine treatment. The focus is on its effects on ocular redness, intraocular pressure (IOP), and eyelid position.

Participant Groups

Group I: Lumify Arm Experimental Treatment 1 Intervention

In each subject, each eye will be randomized to receive a single drop of either Lumify™ (brimonidine tartrate ophthalmic solution 0.025%) or a sterile balanced saline solution.

Group II: Control Arm Placebo Group 1 Intervention

In each subject, each eye will be randomized to receive a single drop of either Lumify™ (brimonidine tartrate ophthalmic solution 0.025%) or a sterile balanced saline solution.

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

James Zanewicz

Tulane University

Chief Medical Officer

MD from Tulane University

Elaine Hamm

Tulane University

Chief Executive Officer since 2022

PhD in Microbiology from the University of Oklahoma