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Recruiting Phase 3 NCT07218796

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

Trial Parameters

Condition Cataract
Sponsor SpyGlass Pharma, Inc.
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 400
Sex ALL
Min Age 22 Years
Max Age N/A
Start Date 2025-10-28
Completion 2029-05-31
Interventions
Bimatoprost Implant SystemSpyGlass IOLTimolol Maleate Ophthalmic Solution, 0.5%

Brief 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

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

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