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Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution
Sponsor: SpyGlass Pharma, Inc.
Summary
This trial is a randomized study to evaluate and compare two doses of 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, Efficacy, and Dose-response of the Bimatoprost Implant System 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
201
Start Date
2023-10-13
Completion Date
2027-11
Last Updated
2025-08-22
Healthy Volunteers
No
Conditions
Interventions
Bimatoprost Implant System (High Dose)
Bimatoprost Implant System (High Dose) used in combination with the SpyGlass IOL
Bimatoprost Implant System (Low Dose)
Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass IOL
Timolol Maleate Ophthalmic Solution, 0.5%
Timolol Maleate Ophthalmic Solution 0.5% BID
Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL
Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens
SpyGlass IOL
SpyGlass Intraocular Lens
Locations (1)
Arizona Advanced Eye Research Institute
Glendale, Arizona, United States