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

Primary Purpose

Glaucoma, Glaucoma, Open-Angle, Glaucoma; Drugs

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
brimonidine tartrate ophthalmic solution 0.025%
sterile balanced saline solution
Sponsored by
Tulane University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tulane University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Lumify Arm

Control Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Ocular redness
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
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
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
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
Measurement of intraocular pressure using handheld tonometer (TonoPen)

Secondary Outcome Measures

Palpebral fissure height
Measurement of distance between inner margin of upper and lower eyelids from clinical photographs
Eye discomfort
Subjective scoring of ocular discomfort by patient on a 0-10 unit scale (0 = very comfortable, 10 = very uncomfortable)

Full Information

First Posted
June 26, 2019
Last Updated
June 13, 2023
Sponsor
Tulane University
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1. Study Identification

Unique Protocol Identification Number
NCT04007276
Brief Title
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
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%
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 10, 2025 (Anticipated)
Primary Completion Date
June 1, 2030 (Anticipated)
Study Completion Date
June 1, 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tulane University

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Glaucoma, Open-Angle, Glaucoma; Drugs, Droopy Eyelid, Ptosis, Glaucoma, Primary Open Angle

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Each patient will be randomized to receive the study medication in one eye and placebo in the other eye.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lumify Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
Sham Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
brimonidine tartrate ophthalmic solution 0.025%
Other Intervention Name(s)
Lumify™
Intervention Description
Single dose of brimonidine tartrate ophthalmic solution 0.025% applied as an eye drop to the eye surface.
Intervention Type
Other
Intervention Name(s)
sterile balanced saline solution
Intervention Description
Single dose of sterile balanced saline solution applied as an eye drop to the eye surface.
Primary Outcome Measure Information:
Title
Ocular redness
Description
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)
Time Frame
5 minutes after application of eye drop
Title
Ocular redness
Description
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)
Time Frame
15 minutes after application of eye drop
Title
Ocular redness
Description
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)
Time Frame
30 minutes after application of eye drop
Title
Ocular redness
Description
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)
Time Frame
60 minutes after application of eye drop
Title
Intraocular pressure
Description
Measurement of intraocular pressure using handheld tonometer (TonoPen)
Time Frame
60 minutes after application of eye drop
Secondary Outcome Measure Information:
Title
Palpebral fissure height
Description
Measurement of distance between inner margin of upper and lower eyelids from clinical photographs
Time Frame
60 minutes after application of eye drop
Title
Eye discomfort
Description
Subjective scoring of ocular discomfort by patient on a 0-10 unit scale (0 = very comfortable, 10 = very uncomfortable)
Time Frame
60 minutes after application of eye drop

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ze Zhang, MD
Phone
504-988-5831
Email
zzhang9@tulane.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sheila Lawshe
Phone
504-988-2261
Email
slawshe@tulane.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ze Zhang, MD
Organizational Affiliation
Tulane University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tulane University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ze Zhang, MD
Phone
504-988-5831
Email
zzhang9@tulane.edu
First Name & Middle Initial & Last Name & Degree
Ze Zhang, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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