GlaucomaPhase 4NCT04007276
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
A Phase 4 study testing brimonidine tartrate ophthalmic solution 0.025% and sterile balanced saline solution in people with Glaucoma and Glaucoma, Open-Angle, run by Tulane University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Glaucoma, Open-Angle, Glaucoma; Drugs
- What is being tested?
- brimonidine tartrate ophthalmic solution 0.025% and sterile balanced saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2027to Nov 2036
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Tulane University Medical Center
New Orleans, Louisiana, 70112
Ze Zhang, MD, 504-988-5831, zzhang9@tulane.edu
Ze Zhang, MD
About this study
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%
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.
- Conditions
- Glaucoma, Glaucoma, Open-Angle, Glaucoma; Drugs, Droopy Eyelid, Ptosis, Glaucoma, Primary Open Angle
- Being tested
- brimonidine tartrate ophthalmic solution 0.025%, sterile balanced saline solution
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brimonidine tartrate ophthalmic solution 0.025%Drug
Also called Lumify™
Single dose of brimonidine tartrate ophthalmic solution 0.025% applied as an eye drop to the eye surface.
sterile balanced saline solutionOther
Single dose of sterile balanced saline solution applied as an eye drop to the eye surface.
| Study group | Role | What they receive |
|---|---|---|
| Lumify Arm | Experimental | 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. Receives: Drug: brimonidine tartrate ophthalmic solution 0.025% |
| Control Arm | Sham comparator | 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. Receives: Other: sterile balanced saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 minutes after application of eye drop
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)
Measured: 15 minutes after application of eye drop
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)
Measured: 30 minutes after application of eye drop
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)
Measured: 60 minutes after application of eye drop
Intraocular pressure
Measurement of intraocular pressure using handheld tonometer (TonoPen)
Measured: 60 minutes after application of eye drop
Secondary outcomes (2)
Palpebral fissure height
Measurement of distance between inner margin of upper and lower eyelids from clinical photographs
Measured: 60 minutes after application of eye drop
Eye discomfort
Subjective scoring of ocular discomfort by patient on a 0-10 unit scale (0 = very comfortable, 10 = very uncomfortable)
Measured: 60 minutes after application of eye drop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study startNov 2027 (estimated)
- Primary completionNov 2031 (estimated)
- Study completionNov 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each patient will be randomized to receive the study medication in one eye and placebo in the other eye.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ze Zhang, MD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007276
- Sponsor's protocol ID
- Lumify Study
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2019
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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%
- ClinicalTrials.gov ID
- NCT04007276
- Acronym / sponsor ID
- Lumify Study
- Conditions
- Glaucoma, Glaucoma, Open-Angle, Glaucoma; Drugs, Droopy Eyelid, Ptosis, Glaucoma, Primary Open Angle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Study start
- Nov 2027 (estimated)
- Primary completion
- Nov 2031 (estimated)
- Study completion
- Nov 2036 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each patient will be randomized to receive the study medication in one eye and placebo in the other eye.
| Arm | Type | Receives |
|---|---|---|
| Lumify Arm | Experimental | Drug: brimonidine tartrate ophthalmic solution 0.025%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. |
| Control Arm | Sham comparator | Other: sterile balanced saline solutionIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Pregnancy
- Prisoners
- Known allergy or sensitivities to brimonidine
- No surgery within the past 6 months
- No history of lid surgery or botox
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brimonidine tartrate ophthalmic solution 0.025%Also: Lumify™Single dose of brimonidine tartrate ophthalmic solution 0.025% applied as an eye drop to the eye surface. | Drug | Lumify Arm |
| sterile balanced saline solutionSingle dose of sterile balanced saline solution applied as an eye drop to the eye surface. | Other | Control Arm |
Primary outcome
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)
2 secondary outcomes
Palpebral fissure height
Time frame: 60 minutes after application of eye drop
Eye discomfort
Time frame: 60 minutes after application of eye drop
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ze Zhang, MD principal investigator
Tulane University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing brimonidine tartrate ophthalmic solution 0.025% and sterile balanced saline solution in people with Glaucoma and Glaucoma, Open-Angle, run by Tulane University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ze Zhang, MD (504-988-5831, zzhang9@tulane.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular redness (time frame: 5 minutes after application of eye drop). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.