Glaucoma is a leading cause of worldwide vision loss, affecting tens of millions of individuals. For clinicians involved in the management of glaucoma, awareness of emerging clinical evidence, including actively recruiting clinical trials, is important for evaluating novel therapies and potential advances in treatment strategies.
Each January is Glaucoma Awareness Month, an opportunity for clinicians to review current guidelines and ongoing clinical trials. In recognition of the awareness month, we have a selection of five ongoing, Phase 3 clinical trials for glaucoma that are currently recruiting in the United States.
Quick View Table of Clinical Trials for Glaucoma
| Study Title | Estimated Enrollment | Start Date | Estimated Completion |
|---|---|---|---|
| Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine) | 400 | October 2025 | March 2031 |
| Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone) | 400 | October 2025 | May 2031 |
| Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant | 610 | June 2025 | March 2032 |
| A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma | 130 | February 2025 | November 2028 |
| Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone | 230 | September 2023 | February 2028 |
Currently Recruiting, Phase 3 Clinical Trials for Glaucoma
Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine)
- Sponsor: SpyGlass Pharma, Inc.
- Goal: This trial is a randomized study to evaluate the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.
- Interventions: Bimatoprost Implant System, SpyGlass IOL, timolol meleate ophthalmic solution, commercial IOL
- Primary Outcome Measures: Mean IOP reduction from baseline (mmHg); BCDVA 20/40 or better
- Time Frames: Weeks two and six and month three; month six
- Study Details
- Source
Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone)
- Sponsor: SpyGlass Pharma, Inc.
- Goal: This trial is a randomized study to evaluate the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol ophthalmic solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.
- Interventions: Bimatoprost Implant System, SpyGlass IOL, timolol maleate ophthalmic solution, 0.5%, commercial IOL
Primary Outcome Measures: Mean IOP reduction from baseline (mmHg); BCDVA 20/40 or better - Time Frames: Weeks two and six, and month three; month six
- Study Details
- Source
Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
- Sponsor: Glaukos Corporation
- Goal: Evaluate the safety and efficacy of the second generation Travoprost Intracameral Implant compared to Timolol Ophthalmic Solution 0.5% administered twice daily in subjects with open-angle glaucoma or ocular hypertension.
- Interventions: Gen 2 Travoprost Intracameral Implant, Timolol eye drops 0.5%, sham procedure, placebo eye drops
- Primary Outcome Measures: Intraocular pressure (IOP)
- Time Frames: Three months
- Study Details
- Source
A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma
- Sponsor: AbbVie
- Goal: This study will assess how safe and effective a glaucoma gel stent is when implanted using the ab interno (inside the eye) and ab externo (outside the eye) approach.
- Interventions: XEN63 Glaucoma Treatment System
- Primary Outcome Measures: Percentage of participants with treatment response of achieving ≥20% reduction in intraocular pressure (IOP) from baseline on the same or fewer number of IOP-lowering medications compared to baseline; Number of participants with adverse events (AEs).
- Time Frame: Month 12; Month 12
- Study Details
- Source
Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone
- Sponsor: Glaukos Corporation
- Goal: Adult subjects with elevated intraocular pressure who have successfully undergone placement of iStent infinite trabecular bypass system will be randomized to receive a travoprost intraocular implant or receive a sham procedure and be followed for 12 months.
- Interventions: Travoprost Intraocular Implant, sham procedure 1, iStent infinite, sham procedure 2
- Primary Outcome Measure: Change from baseline in mean diurnal intraocular pressure (IOP)
- Time Frame: Three months
- Study Details
- Source
Related Guidelines:
- Nicotinamide Use for Glaucoma Neuroprotection
- American Academy of Ophthalmology / American Glaucoma Society, March 2025
- Care of the Patient with Primary Open-Angle Glaucoma
- American Optometric Association, October 2024
- Primary Open-Angle Glaucoma Preferred Practice Pattern
- American Academy of Opthalmology, January 2021
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