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

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ClinicalTrials.gov Identifier: NCT04007276
Recruitment Status : Not yet recruiting
First Posted : July 5, 2019
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
Tulane University

Study Description
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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
Glaucoma Glaucoma, Open-Angle Glaucoma; Drugs Droopy Eyelid Ptosis Glaucoma, Primary Open Angle Drug: brimonidine tartrate ophthalmic solution 0.025% Other: sterile balanced saline solution Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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%
Estimated Study Start Date : November 10, 2025
Estimated Primary Completion Date : June 1, 2030
Estimated Study Completion Date : June 1, 2035

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. Ocular redness [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 60 minutes after application of eye drop ]
    Measurement of intraocular pressure using handheld tonometer (TonoPen)


Secondary Outcome Measures :
  1. Palpebral fissure height [ Time Frame: 60 minutes after application of eye drop ]
    Measurement of distance between inner margin of upper and lower eyelids from clinical photographs

  2. Eye discomfort [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04007276


Contacts
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Contact: Ze Zhang, MD 504-988-5831 zzhang9@tulane.edu
Contact: Sheila Lawshe 504-988-2261 slawshe@tulane.edu

Locations
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United States, Louisiana
Tulane University Medical Center
New Orleans, Louisiana, United States, 70112
Contact: Ze Zhang, MD    504-988-5831    zzhang9@tulane.edu   
Principal Investigator: Ze Zhang, MD         
Sponsors and Collaborators
Tulane University
Investigators
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Principal Investigator: Ze Zhang, MD Tulane University
More Information
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Responsible Party: Tulane University
ClinicalTrials.gov Identifier: NCT04007276    
Other Study ID Numbers: Lumify Study
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Brimonidine Tartrate
Pharmaceutical Solutions
Ophthalmic Solutions
Antihypertensive Agents
 Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs