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

Sponsor
Tulane University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04007276
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
114.7
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase
  • Drug: brimonidine tartrate ophthalmic solution 0.025%
  • Other: sterile balanced saline solution
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Each patient will be randomized to receive the study medication in one eye and placebo in the other eye.Each patient will be randomized to receive the study medication in one eye and placebo in the other eye.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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%
Anticipated Study Start Date :
Nov 10, 2025
Anticipated Primary Completion Date :
Jun 1, 2030
Anticipated Study Completion Date :
Jun 1, 2035

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lumify Arm

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.

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 Names:
  • Lumify™

    		•
    Sham Comparator: Control Arm

    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.

    Other: sterile balanced saline solution
    Single dose of sterile balanced saline solution applied as an eye drop to the eye surface.

    Outcome Measures

    Primary Outcome Measures

    1. 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)

    2. 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)

    3. 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)

    4. 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)

    5. Intraocular pressure [60 minutes after application of eye drop]

      Measurement of intraocular pressure using handheld tonometer (TonoPen)

    Secondary Outcome Measures

    1. Palpebral fissure height [60 minutes after application of eye drop]

      Measurement of distance between inner margin of upper and lower eyelids from clinical photographs

    2. 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 Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tulane University Medical Center New Orleans Louisiana United States 70112

    Sponsors and Collaborators

    • Tulane University

    Investigators

    • Principal Investigator: Ze Zhang, MD, Tulane University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tulane University
    ClinicalTrials.gov Identifier:
    NCT04007276
    Other Study ID Numbers:
    • Lumify Study
    First Posted:
    Jul 5, 2019
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Glaucoma
    Glaucoma, Open-Angle
    Brimonidine Tartrate
    Pharmaceutical Solutions
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Apr 6, 2022