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A197 Ophthalmic Solution for Dry Eye Syndrome

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
Have a history of Dry Eye Disease in both eyes for at least 12 months prior to Visit 1
Written informed consent must be obtained prior to any study-related assessments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial is assessing the safety and effectiveness of a new eye solution for people with Dry Eye Disease.

Eligible Conditions
  • Dry Eye Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You must have written informed consent prior to any study-related assessments.
Select...
You are willing and able to follow instructions and can be present for required study visits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in total corneal fluorescein staining (CFS)
Secondary outcome measures
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still opportunity to join this research initiative?

"As per the information on clinicaltrials.gov, this particular trial has concluded its recruitment phase and is no longer seeking participants. Initially posted on January 25th 2022, it was last updated November 8th 2022. However, 134 other trials are currently accepting patients for enrolment."

Answered by AI

Has the FDA conferred its stamp of approval to A197 Ophthalmic Solution?

"Studied data indicates that A197 Ophthalmic Solution is likely to be safe, so it was assessed a score of 2. This trial has yet to demonstrate any efficacy in clinical trials."

Answered by AI

How many healthcare facilities are engaged in this investigation?

"19 sites are currently enrolling for this trial, such as Aramis Site 121 in Garden Grove, Aramis Site 120 in Glendale, and Aramis Site 113 in Birmingham."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Texas
California
How old are they?
18 - 65
What site did they apply to?
Aramis Site 107
Aramis Site 103
Aramis Site 104
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've tried many dry eye treatments over the years and I'm hoping to discover an effective one.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

~65 spots leftby Mar 2025