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

Cataract Clinical Trial

— Tigris  

Official title:

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%

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06120842
• Other study ID #: SGP-003
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 13, 2023
• Est. completion date: June 2027

Study information

• Verified date: November 2023
• Source: SpyGlass Pharma, Inc.
• Contact: Chris Hafner
• Phone: 18184421564
• Email: chris[@]spyglasspharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 2027
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Glaucoma
• Ocular Hypertension

Intervention

Drug:
• Bimatoprost Implant System (High Dose)
Bimatoprost Implant System (High Dose) used in combination with the SpyGlass IOL
• Bimatoprost Implant System (Low Dose)
Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass IOL
• Timolol Maleate Ophthalmic Solution, 0.5%
Timolol Maleate Ophthalmic Solution 0.5% BID

Device:
• Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL
Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens
• SpyGlass IOL
SpyGlass Intraocular Lens

Locations

Country	Name	City	State
United States	Arizona Advanced Eye Research Institute	Glendale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
SpyGlass Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number and Rates of Adverse Events		Total Study Period of 36 Months
Primary	Mean IOP Reduction from Baseline (mmHg)	Time matched mean IOP reduction from Baseline (mmHg) in the study eyes at all the individual IOP timepoints	Weeks 2 and 6, and Month 3
Secondary	Mean IOP	Time matched mean IOP (mmHg) at Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36	Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36
Secondary	Mean IOP Change from Baseline	Time matched mean IOP change from Baseline (mmHg) at Months 6, 12, 18, 24, 27, 30, 33, and 36	Months 6, 12, 18, 24, 27, 30, 33, and 36
Secondary	Time to postoperative introduction of IOP-lowering medications	Time (Days) to postoperative introduction of IOP-lowering medications (IOP-lowering medications other than the study treatments)	Total Study Period of 36 Months
Secondary	Number of IOP-lowering medications introduced postoperatively	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	Total Study Period of 36 Months
Secondary	Proportion of eyes achieving BCDVA 20/40 or better	Snellen Equivalent	Months 3, 6, and 12
Secondary	Manifest refraction spherical equivalent	Manifest refraction spherical equivalent (MRSE)	Month 3

External Links

•   SpyGlass Pharma Website