NCT07218783

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

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%,

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: SpyGlass Pharma, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract
• Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-10-15
• Primary completion: 2029-03-31
• Completion: 2031-03-31
• First posted: 2025-10-20
• Last updated: 2025-10-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study