NCT06120842
Active, not recruiting
Phase 1
A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety, Efficacy, and Dose-response of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%
SpyGlass Pharma, Inc.1 site in 1 country201 target enrollmentStarted: October 13, 2023Last updated:
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- SpyGlass Pharma, Inc.
- Enrollment
- 201
- Locations
- 1
- Primary Endpoint
- Mean IOP Reduction from Baseline (mmHg)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Bimatoprost Implant System (High Dose) / IOL Combination
Experimental
Intervention: Bimatoprost Implant System (High Dose) (Drug)
Bimatoprost Implant System (High Dose) / IOL Combination
Experimental
Intervention: SpyGlass IOL (Device)
Bimatoprost Implant System (Low Dose) / IOL Combination
Experimental
Intervention: Bimatoprost Implant System (Low Dose) (Drug)
Bimatoprost Implant System (Low Dose) / IOL Combination
Experimental
Intervention: SpyGlass IOL (Device)
Timolol Maleate Ophthalmic Solution 0.5%
Active Comparator
Intervention: Timolol Maleate Ophthalmic Solution, 0.5% (Drug)
Timolol Maleate Ophthalmic Solution 0.5%
Active Comparator
Intervention: Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL (Device)
Outcomes
Primary Outcomes
Mean IOP Reduction from Baseline (mmHg)
Time Frame: 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 Outcomes
- Mean IOP Change from Baseline(Months 6, 12, 18, 24, 27, 30, 33, and 36)
- Proportion of eyes achieving BCDVA 20/40 or better(Months 3, 6, and 12)
- Mean IOP(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)
- Number of IOP-lowering medications introduced postoperatively(Total Study Period of 36 Months)
- Manifest refraction spherical equivalent(Month 3)
Investigators
Study Sites (1)
Loading locations...
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Related News
SpyGlass Pharma Completes Enrollment in Phase I/II Glaucoma Drug Delivery Study• SpyGlass Pharma has finished enrolling patients in its Phase I/II clinical trial evaluating its drug delivery platform for glaucoma and ocular hypertension.
• The platform delivers bimatoprost over three years and is implanted during routine cataract surgery, potentially expanding glaucoma treatment options.
• The company is preparing for an End of Phase II meeting with the FDA to discuss advancing the platform into Phase III pivotal studies.
• SpyGlass's technology aims to improve glaucoma care by integrating treatment into cataract procedures, enhancing adoption among surgeons.SpyGlass Pharma Completes Enrollment in Phase I/II Glaucoma Drug Delivery Study• SpyGlass Pharma has finished enrolling patients in its Phase I/II clinical trial for a novel drug delivery platform targeting glaucoma and ocular hypertension.
• The platform delivers bimatoprost over three years, aiming to reduce intraocular pressure (IOP) via a sustained-release mechanism during cataract surgery.
• The company anticipates engaging with the FDA and moving towards Phase III trials, based on the outcomes of this study and prior first-in-human data.
• The SpyGlass platform could broaden glaucoma treatment during routine cataract procedures, potentially enhancing adoption among surgeons and practices.SpyGlass Pharma Completes Phase I/II Trial Enrollment for Glaucoma Drug Delivery Platform• SpyGlass Pharma has finished enrolling patients in its Phase I/II clinical trial for a novel drug delivery platform designed to treat glaucoma and ocular hypertension.
• The platform delivers bimatoprost over three years during routine cataract surgery, aiming to reduce intraocular pressure (IOP) effectively.
• SpyGlass Pharma is preparing to meet with the FDA to discuss advancing its drug delivery platform to Phase III pivotal studies.
• The innovative platform could broaden glaucoma treatment during cataract procedures, potentially enhancing adoption among surgeons.