NCT07218783PHASE3Recruiting

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

SpyGlass Pharma, Inc.

Start Date

10/15/2025

Completion Date

3/31/2031

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.

Eligibility Criteria

Age Range: 22 years to No maximum

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

Interventions

DRUG

Bimatoprost Implant System

DEVICE

SpyGlass IOL

DRUG

Timolol Maleate Ophthalmic Solution, 0.5%

DEVICE

Commercial IOL

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Conditions

CataractGlaucomaOcular Hypertension

Locations

Houston Eye Associates

Houston, Texas 77025

United States