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
R and R Eye Research, LLC
RECRUITING
San Antonio
Contact Information
Primary
Director, Clinical Affairs
clinical@spyglasspharma.com
949-284-6904
Time Frame
Start Date: 2025-10-28
Estimated Completion Date: 2031-05-31
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.