The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients

The Effect of Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients Using Brimonidine 0.2%, 0.15%, or 0.1%

Glaucoma represents a group of conditions that cause damage to the optic nerve and can lead to irreversible vision loss. Current treatments are aimed at lowering intraocular pressure while minimizing medication side effects. Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) is an FDA-approved medication for alleviating eye redness, a common side effect of glaucoma medications. 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 already using the Brimonidine 0.1%, 0.15% or 0.2% eye drops.

Study Overview

• Status: Not yet recruiting
• Conditions: Glaucoma; Glaucoma, Open-Angle; Ptosis; Glaucoma, Primary Open Angle; Glaucoma; Drugs; Droopy Eyelid
• Intervention / Treatment: Drug: brimonidine tartrate ophthalmic solution 0.025%; Other: sterile balanced saline solution

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ze Zhang, MD; Phone Number: 504-988-5831; Email: zzhang9@tulane.edu
• Study Contact Backup: Name: Whitley Richardson; Phone Number: 504-988-2261; Email: wrichardson@tulane.edu

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Medical Center
      • Contact: Ze Zhang, MD; Phone Number: 504-988-5831; Email: zzhang9@tulane.edu
      • Principal Investigator: Ze Zhang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age > 18 years
• Diagnosis of primary open angle glaucoma
• Willing and able to give informed consent
• Current and greater than 6 weeks of brimonidine 0.2%, 0.15% or 0.1% use

Exclusion Criteria:

• Pregnancy
• Prisoners
• Known allergy or sensitivities to brimonidine
• No surgery within the past 6 months
• No history of lid surgery or botox
• Any other significant ophthalmologic disorder or condition with relevant effect on ocular redness, IOP, or eyelid position as evaluated by principal investigator
• Inability to sit comfortably for 30 minutes
• Prior use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines, or phenylephrine dilating drops within 1 week of study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lumify Arm; 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.	Drug: brimonidine tartrate ophthalmic solution 0.025%; Single dose of brimonidine tartrate ophthalmic solution 0.025% applied as an eye drop to the eye surface.; Other Names: Lumify™
Sham Comparator: Control Arm; 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.	Other: sterile balanced saline solution; Single dose of sterile balanced saline solution applied as an eye drop to the eye surface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular redness	Scoring of ocular redness on clinical photographs using the the Investigator Ocular Redness Scale (0-4; 0 = no ocular redness, 4 = extremely severe ocular redness)	5 minutes after application of eye drop
Ocular redness	Scoring of ocular redness on clinical photographs using the the Investigator Ocular Redness Scale (0-4; 0 = no ocular redness, 4 = extremely severe ocular redness)	15 minutes after application of eye drop
Ocular redness	Scoring of ocular redness on clinical photographs using the the Investigator Ocular Redness Scale (0-4; 0 = no ocular redness, 4 = extremely severe ocular redness)	30 minutes after application of eye drop
Ocular redness	Scoring of ocular redness on clinical photographs using the the Investigator Ocular Redness Scale (0-4; 0 = no ocular redness, 4 = extremely severe ocular redness)	60 minutes after application of eye drop
Intraocular pressure	Measurement of intraocular pressure using handheld tonometer (TonoPen)	60 minutes after application of eye drop

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Palpebral fissure height	Measurement of distance between inner margin of upper and lower eyelids from clinical photographs	60 minutes after application of eye drop
Eye discomfort	Subjective scoring of ocular discomfort by patient on a 0-10 unit scale (0 = very comfortable, 10 = very uncomfortable)	60 minutes after application of eye drop

Collaborators and Investigators

• Sponsor: Tulane University
• Investigators: Principal Investigator: Ze Zhang, MD, Tulane University

Study record dates

Study Major Dates

• Study Start (Estimated): November 10, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2036

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Blepharoptosis; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinoxalines; Brimonidine Tartrate
• Other Study ID Numbers: Lumify Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No