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Not yet recruiting NCT04007276

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

Phase IV Interventional Glaucoma Glaucoma, Open-Angle Glaucoma; Drugs Droopy Eyelid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: brimonidine tartrate ophthalmic solution 0.025%, sterile balanced saline solution.
Who it may be relevant to
Registry conditions: Glaucoma, Glaucoma, Open-Angle, Glaucoma; Drugs, Droopy Eyelid. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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%

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Ocular redness [Time frame: 5 minutes after application of eye drop]
  • Ocular redness [Time frame: 15 minutes after application of eye drop]
  • Ocular redness [Time frame: 30 minutes after application of eye drop]
  • Ocular redness [Time frame: 60 minutes after application of eye drop]
  • Intraocular pressure [Time frame: 60 minutes after application of eye drop]
Secondary outcome measures (2)
  • Palpebral fissure height [Time frame: 60 minutes after application of eye drop]
  • Eye discomfort [Time frame: 60 minutes after application of eye drop]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Tulane University Medical Center — New Orleans

Identifiers

NCT: NCT04007276 · Lumify Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗