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

NCT04007276 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: Lumify Study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glaucoma; Glaucoma, Open-Angle; Glaucoma; Drugs; Droopy Eyelid; Ptosis; Glaucoma, Primary Open Angle

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Palpebral fissure height

  60 minutes after application of eye drop

• Eye discomfort

  60 minutes after application of eye drop

Study Arms (2)

Lumify Arm

EXPERIMENTAL

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%

Control Arm

SHAM COMPARATOR

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

Interventions

brimonidine tartrate ophthalmic solution 0.025% DRUG

Single dose of brimonidine tartrate ophthalmic solution 0.025% applied as an eye drop to the eye surface.

Also known as: Lumify™

Lumify Arm

sterile balanced saline solution OTHER

Single dose of sterile balanced saline solution applied as an eye drop to the eye surface.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tulane University: lead

Study Sites (1)

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle; Blepharoptosis

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Eyelid Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ze Zhang, MD

  Tulane University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ze Zhang, MD

CONTACT

504-988-5831; zzhang9@tulane.edu

Whitley Richardson

CONTACT

504-988-2261; wrichardson@tulane.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patient will be randomized to receive the study medication in one eye and placebo in the other eye.

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 5, 2019
• Study Start (Estimated): November 10, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2036
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)