Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution

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%

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.

Inclusion Criteria:

• Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
• Planned removal of cataract
• Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit and agree to the use of contraception

Exclusion Criteria:

• Uncontrolled systemic disease
• History of incisional/refractive corneal surgery
• Any glaucoma diagnosis other than OHT, open-angle, pseudoexfoliation, or pigmentary glaucoma
• History of incisional glaucoma surgery or intraocular injections
• Other ocular diseases, pathology, or conditions