Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Part of paid clinical trials in Bloomington, Indiana.
- Sponsor
- Brett King
- Study ID
- NCT07847073
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Glaucoma
- Open Angle Glaucoma (OAG)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA] — DRUGNetarsudil ophthalmic solution (Rhopressa) is an FDA-approved Rho kinase inhibitor indicated for the treatment of ocular hypertension and open-angle glaucoma. In this study, participants will instill 1 drop of netarsudil 0.02% ophthalmic solution in the study eye once daily in the evening for 6 months.
- Timolol Maleate 0.25% Ophthalmic Solution — DRUGTimolol maleate ophthalmic solution is an FDA-approved non-selective beta-adrenergic receptor blocking agent indicated for the treatment of ocular hypertension and open-angle glaucoma. In this study, participants will instill 1 drop of timolol maleate 0.25% ophthalmic solution in the study eye twice daily (in the morning and evening) for 6 months.
Study Details
The purpose of this study is to compare how two FDA-approved eye drops: netarsudil (Rhopressa) and timolol, protect nerve cells in the eye of adults with open-angle glaucoma. Both medications lower pressure inside the eye, but researchers want to learn if Rhopressa is more effective at slowing down or preventing the loss of retinal ganglion cells. These cells are essential for sight because they carry visual signals from the eye to the brain. Participants in this study will complete a total of 6 study visits over 12 months: * Participants will spend 6 months using Rhopressa eye drops and 6 months using Timolol eye drops. The order of the two eye drops will be chosen randomly. * At scheduled study visits, researchers will examine participants' eyes and measure eye pressure. * Researchers will take detailed pictures of the back of the eye using a specialized high-resolution camera called adaptive optics optical coherence tomography (AO-OCT). * Participants will also complete specialized visual field testing to measure eye function. Researchers will count and track individual nerve cells over time to determine if one medication offers better protection against cell loss than the other.
Key Dates
- First listed
- Sep 29, 2026
- Start date
- Oct 31, 2026
- Status verified
- Sep 2026
- Primary completion
- Jan 31, 2028
- Completion
- Jan 31, 2028
Study Design
- Enrollment
- 13 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- OTHER
Arms
- Experimental: Rhopressa first, then TimololParticipants will instill netarsudil 0.02% (Rhopressa) ophthalmic solution (1 drop in the study eye once daily in the evening) for the first 6 months (Months 0-6). At the Month 6 visit, participants will cross over to instill timolol maleate 0.25% ophthalmic solution (1 drop in the study eye twice daily) for the remaining 6 months (Months 6-12).
- Experimental: Timolol first, then RhopressaParticipants will instill timolol maleate 0.25% ophthalmic solution (1 drop in the study eye twice daily) for the first 6 months (Months 0-6). At the Month 6 visit, participants will cross over to instill netarsudil 0.02% (Rhopressa) ophthalmic solution (1 drop in the study eye once daily in the evening) for the remaining 6 months (Months 6-12).
Primary Outcome Measure
Change in GC soma density (cells/mm²) [ Time Frame: Baseline, 6 months, and 12 months ]
Central Contacts
- Brett J King, OD, FAAO, Dipl AAO (Glaucoma)(812) 855-1344
- Kaitlyn M Asher, CCRC, BS2194067487
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Indiana University School Of Optometry | Bloomington | Indiana | 47405 | Donald T Miller, PhD (SUB_INVESTIGATOR) Matthew Keller, OD (SUB_INVESTIGATOR) |
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