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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

Tracking Information
First Submitted Date  ICMJE June 26, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date December 21, 2020
Estimated Study Start Date  ICMJE November 10, 2025
Estimated Primary Completion Date June 1, 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • 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)
  • 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)
  • 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)
  • 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)
  • Intraocular pressure [ Time Frame: 60 minutes after application of eye drop ]
    Measurement of intraocular pressure using handheld tonometer (TonoPen)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
Official Title  ICMJE 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%
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Glaucoma
  • Glaucoma, Open-Angle
  • Glaucoma; Drugs
  • Droopy Eyelid
  • Ptosis
  • Glaucoma, Primary Open Angle
Intervention  ICMJE
  • 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™
  • Other: sterile balanced saline solution
    Single dose of sterile balanced saline solution applied as an eye drop to the eye surface.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: brimonidine tartrate ophthalmic solution 0.025%
  • 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.
    Intervention: Other: sterile balanced saline solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2019)		 60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2035
Estimated Primary Completion Date June 1, 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ze Zhang, MD 504-988-5831 zzhang9@tulane.edu
Contact: Sheila Lawshe 504-988-2261 slawshe@tulane.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04007276
Other Study ID Numbers  ICMJE Lumify Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tulane University
Study Sponsor  ICMJE Tulane University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ze Zhang, MD Tulane University
PRS Account Tulane University
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP