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

NCT04007276 — Phase 4, Not yet recruiting, 60 participants, Tulane University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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%

Registry	NCT04007276
Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	60 (Estimated)
Sponsor	Tulane University (Other)
Conditions	Glaucoma, Glaucoma, Open-Angle, Glaucoma; Drugs, Droopy Eyelid, Ptosis, Glaucoma, Primary Open Angle
Interventions	brimonidine tartrate ophthalmic solution 0.025%, sterile balanced saline solution (Drug, other)
Dates	start 2027-11-01 (estimated), primary completion 2031-11-01 (estimated), completion 2036-11-01 (estimated), first posted 2019-07-05, last updated 2026-10-13
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Lumify Arm	Experimental	Drug: 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	Sham comparator	Other: 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.

brimonidine tartrate ophthalmic solution 0.025% (Drug), also known as Lumify™: Single dose of brimonidine tartrate ophthalmic solution 0.025% applied as an eye drop to the eye surface.
sterile balanced saline solution (Other): Single dose of sterile balanced saline solution applied as an eye drop to the eye surface.

+Outcome measures

Primary outcomes

Ocular redness [5 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)
Ocular redness [15 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)
Ocular redness [30 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)
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 outcomes

Palpebral fissure height [60 minutes after application of eye drop]: Measurement of distance between inner margin of upper and lower eyelids from clinical photographs
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)

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Tulane University Medical Center	New Orleans, Louisiana	United States

+Investigators

Ze Zhang, MD, Principal investigator, Tulane University