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RECRUITINGPhase 3INTERVENTIONAL

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%,

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Bimatoprost Implant System

Bimatoprost Implant System used in combination with the SpyGlass IOL

DEVICE

SpyGlass IOL

SpyGlass Intraocular Lens

DRUG

Timolol Maleate Ophthalmic Solution, 0.5%

Timolol Maleate Ophthalmic Solution, 0.5% BID

DEVICE

Commercial IOL

Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens

Locations (1)

R and R Eye Research, LLC
San Antonio, Texas, United States