Brimonidine 0.025% to reduce redness from netarsudil/latanoprost
Impact of Brimonidine Tartrate Ophthalmic 0.025% on Patients Using Netarsudil 0.02%/Latanoprost 0.005% to Treat Glaucoma
This tests whether adding brimonidine tartrate 0.025% eye drops can reduce conjunctival redness in adults with glaucoma or ocular hypertension who are using netarsudil 0.02%/latanoprost 0.005%.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Insight Eyecare Specialties, Inc. dba Vision Source Eyecare, Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT07209410 on ClinicalTrials.gov |
What this trial studies
Adults 18–65 with open‑angle glaucoma or ocular hypertension who have at least grade 2 conjunctival hyperemia after using netarsudil 0.02%/latanoprost 0.005% will receive brimonidine tartrate ophthalmic 0.025% alongside their current regimen. The Phase 4 interventional protocol is conducted at a single Vision Source site and includes baseline and follow‑up visits to measure changes in hyperemia using the Efron scale, monitor visual acuity, and record safety/tolerability. A protocolized washout per FDA guidance for prior topical agents may be required before certain visits. The primary focus is on reduction in ocular redness and treatment tolerability while maintaining intraocular pressure control.
Who should consider this trial
Good fit: Adults aged 18–65 with open‑angle glaucoma or ocular hypertension who have at least grade 2 conjunctival redness after at least four weeks on netarsudil 0.02%/latanoprost 0.005% and can self‑administer eye drops are ideal candidates.
Not a fit: Patients without clinically significant conjunctival hyperemia, those outside the 18–65 age range, or those with allergy to brimonidine are unlikely to receive benefit.
Why it matters
Potential benefit: If successful, adding brimonidine could reduce conjunctival redness and improve tolerability of netarsudil/latanoprost therapy.
How similar studies have performed: Topical alpha‑agonists have been used to reduce ocular redness in other contexts, but this specific combination with netarsudil/latanoprost has limited prior direct evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: 1. Allergy or hypersensitivity to brimonidine or other components of brimonidine tartrate 0.025% or netarsudil 0.02%/latanoprost 0.005%. 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.
Where this trial is running
Kansas City, Missouri
- Vision Source — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Crystal Remington Optometrist, OD
- Email: drremington@vseyecare.com
- Phone: 816-531-9100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.