History of Changes for Study: NCT06120842

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

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Study Record Versions

Version	A	B	Submitted Date	Changes
1			November 1, 2023	None (earliest Version on record)
2			November 8, 2023	Outcome Measures and Study Status

Comparison Format:

Study Identification


Unique Protocol ID:	SGP-003
Brief Title:	Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution (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%
Secondary IDs:

Study Status


Record Verification:	November 2023
Overall Status:	Recruiting
Study Start:	October 13, 2023
Primary Completion:	August 2024 [Anticipated]
Study Completion:	June 2027 [Anticipated]

First Submitted:	November 1, 2023
First Submitted that Met QC Criteria:	November 1, 2023
First Posted:	November 7, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	November 1, 2023
Last Update Posted:	November 7, 2023 [Actual]

Sponsor/Collaborators

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	Yes
Unapproved/Uncleared Device:	Yes
Pediatric Postmarket Surveillance:
Data Monitoring:

Study Description


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:

Conditions


Conditions:	Cataract Glaucoma Ocular Hypertension
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1/Phase 2
Interventional Study Model:	Parallel Assignment
Number of Arms:	3
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	140 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Bimatoprost Implant System (High Dose) / IOL Combination	Drug: Bimatoprost Implant System (High Dose) Bimatoprost Implant System (High Dose) used in combination with the SpyGlass IOL Device: SpyGlass IOL SpyGlass Intraocular Lens
Experimental: Bimatoprost Implant System (Low Dose) / IOL Combination	Drug: Bimatoprost Implant System (Low Dose) Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass IOL Device: SpyGlass IOL SpyGlass Intraocular Lens
Active Comparator: Timolol Maleate Ophthalmic Solution 0.5%	Drug: 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

Outcome Measures


Primary Outcome Measures:
1.	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 Outcome Measures:
1.	Mean IOP [ Time Frame: 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
2.	Mean IOP Change from Baseline [ Time Frame: 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
3.	Time to postoperative introduction of IOP-lowering medications [ Time Frame: Total Study Period of 36 Months ] Time (Days) to postoperative introduction of IOP-lowering medications (IOP-lowering medications other than the study treatments)
4.	Number of IOP-lowering medications introduced postoperatively [ Time Frame: 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
5.	Proportion of eyes achieving BCDVA 20/40 or better [ Time Frame: Months 3, 6, and 12 ] Snellen Equivalent
6.	Manifest refraction spherical equivalent [ Time Frame: Month 3 ] Manifest refraction spherical equivalent (MRSE)
Other Outcome Measures:
1.	Adverse Events [ Time Frame: Total Study Period of 36 Months ]

Eligibility


Minimum Age:	22 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	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

Contacts/Locations


Central Contact Person:	Chris Hafner Telephone: 18184421564 Email: chris@spyglasspharma.com
Study Officials:	Chris Hafner Study Chair SpyGlass Pharma, Inc.
Locations:	United States, Arizona
	Arizona Advanced Eye Research Institute [Recruiting] Glendale, Arizona, United States, 85306 Contact:Contact: Pat Dawson

IPDSharing


Plan to Share IPD:

References


Citations:
Links:	URL: https://www.spyglasspharma.com/ Description: SpyGlass Pharma Website
Available IPD/Information: