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

Phase 4

Not yet recruiting

• Conditions: Ptosis; Glaucoma, Primary Open Angle; Glaucoma; Glaucoma, Open-Angle; Glaucoma; Drugs; Droopy Eyelid
• Interventions: Drug: brimonidine tartrate ophthalmic solution 0.025%; Other: sterile balanced saline solution

• Registration Number: NCT04007276
• Lead Sponsor: Tulane University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Study Start: 2025-11-10
• Primary Completion: 2030-06-01
• Study Completion: 2035-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumify Arm	brimonidine tartrate ophthalmic solution 0.025%	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.
Control Arm	sterile balanced saline solution	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.

Primary Outcome Measures

Name	Time	Method
Ocular redness	60 minutes after application of eye drop	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)
Intraocular pressure	60 minutes after application of eye drop	Measurement of intraocular pressure using handheld tonometer (TonoPen)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tulane University Medical Center; 🇺🇸 New Orleans, Louisiana, United States