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

Phase 1

Active, not recruiting

• Conditions: Ocular Hypertension; Glaucoma; Cataract
• Interventions: Drug: Timolol Maleate Ophthalmic Solution, 0.5%; Drug: Bimatoprost Implant System (High Dose); Drug: Bimatoprost Implant System (Low Dose); Device: Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL; Device: SpyGlass IOL

• Registration Number: NCT06120842
• Lead Sponsor: SpyGlass Pharma, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-13
• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2023-11-01
• Study First Posted: 2023-11-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-11
• Primary Completion: 2025-01-22
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 201

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Timolol Maleate Ophthalmic Solution 0.5%	Timolol Maleate Ophthalmic Solution, 0.5%	-
Timolol Maleate Ophthalmic Solution 0.5%	Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL	-
Bimatoprost Implant System (High Dose) / IOL Combination	Bimatoprost Implant System (High Dose)	-
Bimatoprost Implant System (Low Dose) / IOL Combination	SpyGlass IOL	-
Bimatoprost Implant System (High Dose) / IOL Combination	SpyGlass IOL	-
Bimatoprost Implant System (Low Dose) / IOL Combination	Bimatoprost Implant System (Low Dose)	-

Primary Outcome Measures

Name	Time	Method
Mean IOP Reduction from Baseline (mmHg)	Weeks 2 and 6, and Month 3	Time matched mean IOP reduction from Baseline (mmHg) in the study eyes at all the individual IOP timepoints

Secondary Outcome Measures

Name	Time	Method
Mean IOP Change from Baseline	Months 6, 12, 18, 24, 27, 30, 33, and 36	Time matched mean IOP change from Baseline (mmHg) at Months 6, 12, 18, 24, 27, 30, 33, and 36
Mean IOP	Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36	Time matched mean IOP (mmHg) at Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36
Time to postoperative introduction of IOP-lowering medications	Total Study Period of 36 Months	Time (Days) to postoperative introduction of IOP-lowering medications (IOP-lowering medications other than the study treatments)
Number of IOP-lowering medications introduced postoperatively	Total Study Period of 36 Months	Number of IOP-lowering medications introduced postoperatively (N) at Weeks 2 and 6, and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36
Proportion of eyes achieving BCDVA 20/40 or better	Months 3, 6, and 12	Snellen Equivalent
Manifest refraction spherical equivalent	Month 3	Manifest refraction spherical equivalent (MRSE)

Trial Locations

Locations (1)

Arizona Advanced Eye Research Institute; 🇺🇸 Glendale, Arizona, United States