Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone)

SpyGlass Pharma, Inc.

Status and phase: Enrolling; Phase 3

Conditions: Cataract; Glaucoma; Ocular Hypertension

Treatments: Device: SpyGlass IOL; Drug: Bimatoprost Implant System; Drug: Timolol Maleate Ophthalmic Solution, 0.5%; Device: Commercial IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT07218796

SGP-006

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups

Bimatoprost Implant System / IOL Combination

Experimental group

Treatment:

Drug: Bimatoprost Implant System

Device: SpyGlass IOL

Timolol Maleate Ophthalmic Solution 0.5%

Active Comparator group

Treatment:

Device: Commercial IOL

Drug: Timolol Maleate Ophthalmic Solution, 0.5%