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)
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.
ClinicalTrials.gov IDNCT07218796
PhasePHASE3
Enrollment400
SponsorSpyGlass Pharma, Inc.
Age22 Years and older
SexALL
Conditions studied
Cataract, Glaucoma, Ocular Hypertension
About this study
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.
Interventions
- Drug: Bimatoprost Implant System — Bimatoprost Implant System used in combination with the SpyGlass IOL
- Device: SpyGlass IOL — SpyGlass Intraocular Lens
- Drug: Timolol Maleate Ophthalmic Solution, 0.5% — Timolol Maleate Ophthalmic Solution, 0.5% BID
- Device: Commercial IOL — Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens
Primary outcomes
- Mean IOP Reduction from Baseline (mmHg) (Weeks 2 and 6, and Month 3)
- BCDVA 20/40 or better (Month 6)
Eligibility information
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
Study locations
- R and R Eye Research, LLC, San Antonio, Texas 78229 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-28.