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Lumify for Glaucoma Side Effects

Phase 4
Waitlist Available
Led By Ze Zhang, MD
Research Sponsored by Tulane University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of primary open angle glaucoma
Age > 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes after application of eye drop
Awards & highlights

Study Summary

This trial will test whether Lumify can help reduce side effects for people with glaucoma who are already using another medication.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Lumify™ may cause minor eye irritation, dry mouth, drowsiness, or mild headaches as side effects based on previous knowledge about Brimonidine solutions used in similar concentrations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with primary open angle glaucoma.
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I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes after application of eye drop
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 minutes after application of eye drop for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intraocular pressure
Ocular redness
Secondary outcome measures
Eye discomfort
Palpebral fissure height

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lumify ArmExperimental Treatment1 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 ArmPlacebo Group1 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.

Find a Location

Who is running the clinical trial?

Tulane UniversityLead Sponsor
117 Previous Clinical Trials
237,565 Total Patients Enrolled
Ze Zhang, MDPrincipal InvestigatorTulane University

Media Library

brimonidine tartrate ophthalmic solution 0.025% Clinical Trial Eligibility Overview. Trial Name: NCT04007276 — Phase 4
Glaucoma Research Study Groups: Lumify Arm, Control Arm
Glaucoma Clinical Trial 2023: brimonidine tartrate ophthalmic solution 0.025% Highlights & Side Effects. Trial Name: NCT04007276 — Phase 4
brimonidine tartrate ophthalmic solution 0.025% 2023 Treatment Timeline for Medical Study. Trial Name: NCT04007276 — Phase 4
~40 spots leftby Jun 2030
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