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

Glaucoma Clinical Trial

Official title:

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%

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04007276
• Other study ID #: Lumify Study
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

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

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