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.
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
- Age range
- 22+ years
- Sex
- All
- 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
Interventions
- DrugBimatoprost Implant System
Bimatoprost Implant System used in combination with the SpyGlass IOL
- DeviceSpyGlass IOL
SpyGlass Intraocular Lens
- DrugTimolol Maleate Ophthalmic Solution, 0.5%
Timolol Maleate Ophthalmic Solution, 0.5% BID
- DeviceCommercial IOL
Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens
Location
- Houston Eye AssociatesHouston, Texas