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

NCT07218783 · SpyGlass Pharma, Inc.

Recruiting

In plain English

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Official title

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%,

About this study

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

Study design

Enrollment target: 400 participants

Allocation: randomized

Masking: double

Age groups: adult, older_adult

Timeline

Starts: 2025-10-15

Estimated completion: 2031-03-31

Last updated: 2025-10-20

Interventions

Drug: Bimatoprost Implant SystemDevice: SpyGlass IOLDrug: Timolol Maleate Ophthalmic Solution, 0.5%Device: Commercial IOL

Primary outcomes

• Mean IOP Reduction from Baseline (mmHg) (Weeks 2 and 6, and Month 3)
• BCDVA 20/40 or better (Month 6)

Sponsor

SpyGlass Pharma, Inc. · industry

Contacts & investigators

ContactDirector, Clinical Affairs · contact · clinical@spyglasspharma.com · 949-284-6904

InvestigatorPaul Yoo, OD · study_chair, SpyGlass Pharma

All locations (1)

Houston Eye AssociatesRecruiting

Houston, Texas, United States

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