Evaluating Injection With the Use of Brimonidine Tartrate Ophthalmic 0.025% on Patients Using Netarsudil 0.02%/Latanoprost 0.005% to Treat Glaucoma
NCT ID: NCT07209410
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
35 participants
INTERVENTIONAL
2025-11-01
2027-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Brimonidine Tartrate
Patients experiencing hyperemia greater than grade 2 on Efron scale will receive brimonidine tartrate (Lumify). Photo documentation of hyperemia and patient satisfaction questionnaires will be administered.
Brimonidine Tartrate Ophthalmic 0.025%
Lumify is an approved eye drop to minimize ocular hyperemia.
Interventions
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Brimonidine Tartrate Ophthalmic 0.025%
Lumify is an approved eye drop to minimize ocular hyperemia.
Eligibility Criteria
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Inclusion Criteria
2\. Currently on netarsudil 0.02%/latanoprost 0.005% monotherapy for a minimum of 2-6 weeks.
3\. Able to move from current topical glaucoma treatment to netarsudil 0.02%/latanoprost 0.005% for a minimum of 4 weeks or longer based on FDA recommended washout per drug classification prior to Visit 3.
4\. Experience conjunctival redness as graded on the Efron scale of at least grade 2 after minimum of 4 weeks on netarsudil 0.02%/latanoprost 0.005% mono-therapy or longer based on recommended washout per drug classification 4. Have a best corrected Visual Acuity by Snellen chart of 20/30 or better in study eye.
5\. Are willing and able to self-administer or have an able person available to assist with administration of study drug.
Willing and able to comply with study procedures and attend follow-up visits.
Exclusion Criteria
2. Use of any other topical ocular medications.
3. Active ocular infection, inflammation unrelated to glaucoma therapy, uveitis, iritis or congenital aphakia.
4. Have pterygium/pinguecula, chemosis, episcleritis, scleritis (or any condition that may affect hyperemia grading) in the opinion of the investigator
5. Have moderate or severe dry eyes.
6. Pregnant, plan to become pregnant or breastfeeding.
7. Concurrent or past use in the last 90 days of vasoconstrictive ocular drops other than brimondine 0.025%
8. Have undergone previous incision IOP lowering surgeries.
9. Have undergone previous laser surgery for glaucoma (selective laser trabeculoplasty (SLT) or argon laser trabeculoplasty (ALT)), or microinvasive glaucoma surgery (MIGS) with 6 months of screening.
10. Have had intraocular or per-ocular surgery within the past 3 months.
11. Advanced glaucoma or c/d ratio greater than 0.8. Are non-responsive to topical treatment with netarsudil 0.02%/latanoprost 0.005%.
12. In the judgement of the investigator, have previous or currently active clinically significant systemic or ocular disease in either eye that could affect study outcomes.
18 Years
65 Years
ALL
Yes
Sponsors
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Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,
OTHER
Responsible Party
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Crystal Remington
Optometrist
Locations
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Vision Source
Kansas City, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VSE002
Identifier Type: -
Identifier Source: org_study_id
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