Lumify for Glaucoma Side Effects

Overseen By Whitley Richardson

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Tulane University

Must be taking: Brimonidine

Must not be taking: Eye whiteners, Decongestants

Disqualifiers: Pregnancy, Allergy to brimonidine, 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: 2

Duration: 1 day

60 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single drop of either Lumify™ or a sterile balanced saline solution in each eye

1 day

1 visit (in-person)

Follow-up

Participants are monitored for ocular redness, intraocular pressure, and eyelid position 60 minutes after application

1 hour

1 visit (in-person)

Treatment Details

Interventions

• Brimonidine Tartrate Ophthalmic Solution 0.025%

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+