Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution (Tigris)

SpyGlass Pharma, Inc.

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Cataract; Glaucoma; Ocular Hypertension

Treatments: Drug: Timolol Maleate Ophthalmic Solution, 0.5%; Drug: Bimatoprost Implant System (Low Dose); Drug: Bimatoprost Implant System (High Dose); Device: Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL; Device: SpyGlass IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT06120842

SGP-003

Details and patient eligibility

About

This trial is a randomized study to evaluate and compare two doses of 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: 201 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, pseudoexfoliation, 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: Quadruple Blind

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201 participants in 3 patient groups

Bimatoprost Implant System (High Dose) / IOL Combination

Experimental group

Treatment:

Device: SpyGlass IOL

Drug: Bimatoprost Implant System (High Dose)

Bimatoprost Implant System (Low Dose) / IOL Combination

Experimental group

Treatment:

Device: SpyGlass IOL

Drug: Bimatoprost Implant System (Low Dose)

Timolol Maleate Ophthalmic Solution 0.5%

Active Comparator group

Treatment:

Device: Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL

Drug: Timolol Maleate Ophthalmic Solution, 0.5%