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

Study Overview
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Brief Summary
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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.

Official Title
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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%

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

Intervention / Treatment
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* Drug: brimonidine tartrate ophthalmic solution 0.025%
* Other: sterile balanced saline solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each patient will be randomized to receive the study medication in one eye and placebo in the other eye.
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |