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Bimatoprost Implant + SpyGlass Lens for Glaucoma/Ocular Hypertension (Tigris Trial)
Phase 1 & 2
Recruiting
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
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
Tigris Trial 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.Check my eligibility
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.See study design
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.
Tigris Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for cataract surgery.
Select...
I have been diagnosed with mild to moderate open-angle glaucoma or high eye pressure.
Tigris Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 2 and 6 and months 3, 6, 12, 18, 24, 27, 30, 33, and 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 2 and 6 and months 3, 6, 12, 18, 24, 27, 30, 33, and 36
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean IOP Reduction from Baseline (mmHg)
Secondary outcome measures
Manifest refraction spherical equivalent
Mean IOP
Mean IOP Change from Baseline
+3 moreOther outcome measures
Number and Rates of Adverse Events
Tigris 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
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Who is running the clinical trial?
SpyGlass Pharma, Inc.Lead Sponsor
Chris HafnerStudy ChairSpyGlass Pharma, Inc.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any remaining vacancies in this clinical trial?
"Affirmative. Clinicaltrials.gov reflects that this medical research is currently recruiting participants, with the initial posting being published on October 13th 2023 and last revised November 1st 2023. The study aims to enrol 140 individuals at a single site of recruitment."
Answered by AI
How many participants are currently recruited for this clinical trial?
"Affirmative, clinicaltrials.gov has information indicating that this experiment is actively searching for participants. It was first posted on October 13th 2023 and recently updated on November 1st 2023. The recruitment goal is to find 140 patients at a single site."
Answered by AI
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