NCT07218783
Recruiting
Phase 3
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%,
SpyGlass Pharma, Inc.1 site in 1 country400 target enrollmentStarted: October 15, 2025Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- SpyGlass Pharma, Inc.
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Mean IOP Reduction from Baseline (mmHg)
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Bimatoprost Implant System / IOL Combination
Experimental
Intervention: Bimatoprost Implant System (Drug)
Bimatoprost Implant System / IOL Combination
Experimental
Intervention: SpyGlass IOL (Device)
Timolol Maleate Ophthalmic Solution 0.5%
Active Comparator
Intervention: Timolol Maleate Ophthalmic Solution, 0.5% (Drug)
Timolol Maleate Ophthalmic Solution 0.5%
Active Comparator
Intervention: Commercial IOL (Device)
Outcomes
Primary Outcomes
Mean IOP Reduction from Baseline (mmHg)
Time Frame: Weeks 2 and 6, and Month 3
Time-matched mean IOP change from Baseline in the study eyes at all the individual IOP timepoints
BCDVA 20/40 or better
Time Frame: Month 6
Study eyes achieving best corrected distance visual acuity (BCDVA) of 20/40 or better
Secondary Outcomes
- Mean IOP Reduction from Baseline (mmHg)(Month 6, 9 and 12)
Investigators
Study Sites (1)
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