Recruiting
Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine)
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 IDNCT07218783
PhasePHASE3
Enrollment400
SponsorSpyGlass Pharma, Inc.
Age22 Years
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
- Houston Eye Associates, Houston, Texas 77025 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: 2026-09-27.