Status:
RECRUITING
Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone)
Lead Sponsor:
SpyGlass Pharma, Inc.
Conditions:
Cataract
Glaucoma
Eligibility:
All Genders
22+ years
Phase:
PHASE3
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 gl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2031
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT07218796
Start Date
October 28 2025
End Date
May 31 2031
Last Update
October 20 2025
Active Locations (1)
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1
R and R Eye Research, LLC
San Antonio, Texas, United States, 78229