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
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Condition or disease | Intervention/treatment | Phase |
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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 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 |
Arm | Intervention/treatment |
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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.
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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.
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Other: sterile balanced saline solution
Single dose of sterile balanced saline solution applied as an eye drop to the eye surface. |
- 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)
- 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)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

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
Contact: Ze Zhang, MD | 504-988-5831 | zzhang9@tulane.edu | |
Contact: Sheila Lawshe | 504-988-2261 | slawshe@tulane.edu |
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 |
Principal Investigator: | Ze Zhang, MD | Tulane University |
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 |
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 |
Glaucoma Glaucoma, Open-Angle Ocular Hypertension Eye Diseases Brimonidine Tartrate Pharmaceutical Solutions Ophthalmic Solutions Antihypertensive Agents |
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