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Beta Blocker

Bimatoprost Implant + SpyGlass Lens for Glaucoma/Ocular Hypertension (Tigris Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by SpyGlass Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planned removal of cataract
Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
Must not have
Uncontrolled systemic disease
History of incisional/refractive corneal surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 2 and 6 and months 3, 6, 12, 18, 24, 27, 30, 33, and 36
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two doses of an implant to lower eye pressure in those with glaucoma or ocular hypertension during cataract surgery.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include eye irritation, redness, changes in vision, dry eyes, and possibly allergic reactions. The exact side effects will depend on the individual's response to the implant system or ophthalmic solution.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for cataract surgery.
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I have been diagnosed with mild to moderate open-angle glaucoma or high eye pressure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a disease that is not currently under control.
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I have had surgery to correct my vision.
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I have had surgery for glaucoma or injections in my eye.
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I have a type of glaucoma that is not OHT, open-angle, pseudoexfoliation, or pigmentary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 2 and 6 and months 3, 6, 12, 18, 24, 27, 30, 33, and 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 2 and 6 and months 3, 6, 12, 18, 24, 27, 30, 33, and 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean IOP Reduction from Baseline (mmHg)
Secondary study objectives
Manifest refraction spherical equivalent
Mean IOP
Mean IOP Change from Baseline
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Bimatoprost Implant System (Low Dose) / IOL CombinationExperimental Treatment2 Interventions
Group II: Bimatoprost Implant System (High Dose) / IOL CombinationExperimental Treatment2 Interventions
Group III: Timolol Maleate Ophthalmic Solution 0.5%Active Control2 Interventions

Find a Location

Who is running the clinical trial?

SpyGlass Pharma, Inc.Lead Sponsor
Chris HafnerStudy ChairSpyGlass Pharma, Inc.
~13 spots leftby Jan 2025
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