Status:
RECRUITING
Evaluating Injection With the Use of Brimonidine Tartrate Ophthalmic 0.025% on Patients Using Netarsudil 0.02%/Latanoprost 0.005% to Treat Glaucoma
Lead Sponsor:
Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,
Conditions:
Glaucoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
To evaluate the effect of brimonidine tartrate 0.025% on conjunctival hyperemia in patients treated with netarsudil 0.02%/latanoprost 0.005% mono-therapy for intraocular pressure lowering.
Eligibility Criteria
Inclusion
- 1\. Adult patients 18-65 years old diagnosed with open-angle glaucoma or ocular hypertension.
- 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
- Allergy or hypersensitivity to brimonidine or other components of brimonidine tartrate 0.025% or netarsudil 0.02%/latanoprost 0.005%.
- Use of any other topical ocular medications.
- Active ocular infection, inflammation unrelated to glaucoma therapy, uveitis, iritis or congenital aphakia.
- Have pterygium/pinguecula, chemosis, episcleritis, scleritis (or any condition that may affect hyperemia grading) in the opinion of the investigator
- Have moderate or severe dry eyes.
- Pregnant, plan to become pregnant or breastfeeding.
- Concurrent or past use in the last 90 days of vasoconstrictive ocular drops other than brimondine 0.025%
- Have undergone previous incision IOP lowering surgeries.
- 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.
- Have had intraocular or per-ocular surgery within the past 3 months.
- Advanced glaucoma or c/d ratio greater than 0.8. Are non-responsive to topical treatment with netarsudil 0.02%/latanoprost 0.005%.
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT07209410
Start Date
November 1 2025
End Date
June 1 2027
Last Update
November 18 2025
Active Locations (1)
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1
Vision Source
Kansas City, Missouri, United States, 64111