NCT06120842

Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution

A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety, Efficacy, and Dose-response of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: SpyGlass Pharma, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This trial is a randomized study to evaluate and compare two doses of 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 (High Dose)	Bimatoprost Implant System (High Dose) used in combination with the SpyGlass IOL
DRUG	Bimatoprost Implant System (Low Dose)	Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass IOL
DRUG	Timolol Maleate Ophthalmic Solution, 0.5%	Timolol Maleate Ophthalmic Solution 0.5% BID
DEVICE	Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL	Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens
DEVICE	SpyGlass IOL	SpyGlass Intraocular Lens

Timeline

• Start date: 2023-10-13
• Primary completion: 2025-01-31
• Completion: 2027-11-01
• First posted: 2023-11-07
• Last updated: 2025-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study