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NCT04007276 | NOT YET RECRUITING | Glaucoma

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

Tulane University

Brief 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.

Condition or disease

Glaucoma

Glaucoma, Open-Angle

Glaucoma; Drugs

Droopy Eyelid

Ptosis

Glaucoma, Primary Open Angle

Intervention/treatment

brimonidine tartrate ophthalmic solution 0.025%

sterile balanced saline solution

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
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%
Actual Study Start Date : 2025-11-10
Estimated Primary Completion Date : 2030-06-01
Estimated Study Completion Date : 2035-06-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients

Location Details

NCT04007276

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How to Participate

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Locations

Not yet recruiting

United States, Louisiana

Tulane University Medical Center

New Orleans, Louisiana, United States, 70112