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
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:
• 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
Locations
United States
Texas
Houston Eye Associates
RECRUITING
Houston
Contact Information
Primary
Director, Clinical Affairs
clinical@spyglasspharma.com
949-284-6904
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2031-03-31
Participants
Target number of participants: 400
Treatments
Experimental: Bimatoprost Implant System / IOL Combination
Active_comparator: Timolol Maleate Ophthalmic Solution 0.5%
Related Therapeutic Areas
Sponsors
Leads: SpyGlass Pharma, Inc.