Bimatoprost Implant + SpyGlass Lens for Glaucoma/Ocular Hypertension

(Tigris Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: SpyGlass Pharma, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Chris Hafner

Principal Investigator

SpyGlass Pharma, Inc.

Eligibility Criteria

This trial is for adults with mild to moderate open-angle glaucoma or ocular hypertension who are also undergoing cataract surgery. Participants must not have other types of glaucoma, uncontrolled diseases, a history of certain eye surgeries, or additional eye conditions.

Inclusion Criteria

I am scheduled for cataract surgery.

I am a woman who can have children, not pregnant, and agree to use birth control.

I have been diagnosed with mild to moderate open-angle glaucoma or high eye pressure.

Exclusion Criteria

I have no other eye diseases or conditions.

I have had surgery for glaucoma or injections in my eye.

I have a disease that is not currently under control.

Treatment Details

Interventions

• Bimatoprost Implant System (High Dose) (Prostaglandin Analog)
• Bimatoprost Implant System (Low Dose) (Prostaglandin Analog)
• Timolol Maleate Ophthalmic Solution, 0.5% (Beta Blocker)

Trial Overview The study compares two doses of the Bimatoprost Implant System combined with SpyGlass IOL against Timolol Ophthalmic Solution in patients having cataract surgery and living with specific types of glaucoma or high eye pressure.

Participant Groups

Group I: Bimatoprost Implant System (Low Dose) / IOL Combination Experimental Treatment 2 Interventions

Group II: Bimatoprost Implant System (High Dose) / IOL Combination Experimental Treatment 2 Interventions

Group III: Timolol Maleate Ophthalmic Solution 0.5% Active Control 2 Interventions

Who Is Running the Clinical Trial?

SpyGlass Pharma, Inc.

Lead Sponsor

Trials

1

Recruited

200+