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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04007276
Other study ID # Lumify Study
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date November 10, 2025
Est. completion date June 1, 2035

Study information

Verified date June 2023
Source Tulane University
Contact Ze Zhang, MD
Phone 504-988-5831
Email zzhang9@tulane.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date June 1, 2035
Est. primary completion date June 1, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Drug:
brimonidine tartrate ophthalmic solution 0.025%
Single dose of brimonidine tartrate ophthalmic solution 0.025% applied as an eye drop to the eye surface.
Other:
sterile balanced saline solution
Single dose of sterile balanced saline solution applied as an eye drop to the eye surface.

Locations

Country Name City State
United States Tulane University Medical Center New Orleans Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Tulane University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary Intraocular pressure Measurement of intraocular pressure using handheld tonometer (TonoPen) 60 minutes after application of eye drop
Secondary Palpebral fissure height Measurement of distance between inner margin of upper and lower eyelids from clinical photographs 60 minutes after application of eye drop
Secondary 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
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