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

Tulane University

Status and phase: Begins enrollment in 6 months; Phase 4

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

Treatments: Other: sterile balanced saline solution; Drug: brimonidine tartrate ophthalmic solution 0.025%

Study type: Interventional

Funder types: Other

Identifiers

NCT04007276

Lumify Study

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Lumify Arm

Experimental group

Description:

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.

Treatment:

Drug: brimonidine tartrate ophthalmic solution 0.025%

Control Arm

Sham Comparator group

Description:

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.

Treatment:

Other: sterile balanced saline solution