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

• Sponsor: SpyGlass Pharma, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06120842
• Collaborator: (none)
• Enrollment: 140
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 43.6
• Patients Per Site Per Month: 3.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract; Glaucoma; Ocular Hypertension	Drug: Bimatoprost Implant System (High Dose); Drug: Bimatoprost Implant System (Low Dose); Drug: Timolol Maleate Ophthalmic Solution, 0.5%; Device: Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL; Device: SpyGlass IOL	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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%
• Actual Study Start Date: Oct 13, 2023
• Anticipated Primary Completion Date: Aug 1, 2024
• Anticipated Study Completion Date: Jun 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
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) [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 [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 [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 [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 [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 [Months 3, 6, and 12]

   Snellen Equivalent

6. Manifest refraction spherical equivalent [Month 3]

   Manifest refraction spherical equivalent (MRSE)

Other Outcome Measures

1. Number and Rates of Adverse Events [Total Study Period of 36 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Advanced Eye Research Institute	Glendale	Arizona	United States	85306

Sponsors and Collaborators

• SpyGlass Pharma, Inc.

Investigators

• Study Chair: Chris Hafner, SpyGlass Pharma, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• SpyGlass Pharma Website

Publications

None provided.

• Responsible Party: SpyGlass Pharma, Inc.
• ClinicalTrials.gov Identifier: NCT06120842
• Other Study ID Numbers: SGP-003
• First Posted: Nov 7, 2023
• Last Update Posted: Nov 10, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Cataract; Ocular Hypertension; Timolol; Bimatoprost; Ophthalmic Solutions

Study Results

No Results Posted as of Nov 10, 2023