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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.
Summary
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.
Official title: A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety and Efficacy of the Bimatoprost Implant System (78 mcg) Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%,
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2025-10-28
Completion Date
2031-05-31
Last Updated
2025-10-20
Healthy Volunteers
No
Conditions
Interventions
Bimatoprost Implant System
Bimatoprost Implant System used in combination with the SpyGlass IOL
SpyGlass IOL
SpyGlass Intraocular Lens
Timolol Maleate Ophthalmic Solution, 0.5%
Timolol Maleate Ophthalmic Solution, 0.5% BID
Commercial IOL
Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens
Locations (1)
R and R Eye Research, LLC
San Antonio, Texas, United States