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

NCT ID: NCT04007276

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-11-10
• Study Completion Date: 2036-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

brimonidine tartrate ophthalmic solution 0.025%

Intervention Type: DRUG

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

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.

Group Type: SHAM_COMPARATOR

sterile balanced saline solution

Intervention Type: OTHER

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

Interventions

brimonidine tartrate ophthalmic solution 0.025%

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

Intervention Type: DRUG

sterile balanced saline solution

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

Intervention Type: OTHER

Other Intervention Names

Lumify™

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tulane University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ze Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Tulane University

Locations

Tulane University Medical Center

New Orleans, Louisiana, United States

Countries

United States

Central Contacts

Ze Zhang, MD

Role: CONTACT

zzhang9@tulane.edu

504-988-5831

Whitley Richardson

Role: CONTACT

wrichardson@tulane.edu

504-988-2261

Facility Contacts

Ze Zhang, MD

Role: primary

zzhang9@tulane.edu

504-988-5831

Other Identifiers

Lumify Study

Identifier Type: -

Identifier Source: org_study_id