RecruitingPhase 3NCT07218796

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%,


Sponsor

SpyGlass Pharma, Inc.

Enrollment

400 participants

Start Date

Oct 28, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study (called Rhone) is testing the safety and effectiveness of a bimatoprost implant — a small device placed inside the eye that slowly releases glaucoma medication — when used together with a new type of intraocular lens (SpyGlass IOL) during cataract surgery. The Rhone study is a companion to the Rhine study, and both evaluate whether this combination reduces eye pressure better than standard eye drops. **You may be eligible if...** - You have mild to moderate open-angle glaucoma or elevated eye pressure (ocular hypertension) - You are scheduled to have cataract removal surgery - If you are a woman of childbearing age, you are willing to use contraception and have a negative pregnancy test **You may NOT be eligible if...** - You have an uncontrolled systemic (whole-body) disease - You have had previous corneal surgery (such as LASIK or PRK) - Your glaucoma is a type other than open-angle, pseudoexfoliative, or pigmentary glaucoma - You have had previous glaucoma surgery or intraocular injections - You have other significant eye diseases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBimatoprost Implant System

Bimatoprost Implant System used in combination with the SpyGlass IOL

DEVICESpyGlass IOL

SpyGlass Intraocular Lens

DRUGTimolol Maleate Ophthalmic Solution, 0.5%

Timolol Maleate Ophthalmic Solution, 0.5% BID

DEVICECommercial IOL

Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens


Locations(1)

R and R Eye Research, LLC

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07218796


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