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A Study to Evaluate the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease
Phase 2
Waitlist Available
Research Sponsored by Aramis Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trial is testing an eye drop called A197 to see if it is safe and effective for people with Dry Eye Disease. The goal is to find out if it can help reduce the discomfort and vision issues caused by this condition.
Eligible Conditions
- Dry Eye Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in total corneal fluorescein staining (CFS)
Secondary study objectives
Change from baseline in bulbar conjunctival hyperemia (CCLRU)
Change from baseline in eye dryness via the Visual Analogue Scale (VAS)
Change from baseline in lissamine green conjunctival staining (LGCS)
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: A197 Ophthalmic Solution, Low DoseExperimental Treatment1 Intervention
Group II: A197 Ophthalmic Solution, High DoseExperimental Treatment1 Intervention
Group III: Active ComparatorActive Control1 Intervention
Group IV: A197 Vehicle ControlPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
A197 Ophthalmic Solution
2022
Completed Phase 2
~210
Find a Location
Who is running the clinical trial?
Aramis Biosciences, Inc.Lead Sponsor
David S Tierney, MDStudy DirectorAramis Biosciences