Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone)

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%,

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.

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, pseudoexfoliative, or pigmentary glaucoma
• History of incisional glaucoma surgery or intraocular injections
• Other ocular diseases, pathology, or conditions