A Study to Evaluate the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease

May 15, 2023 updated by: Aramis Biosciences, Inc.

A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled Clinical Trial Evaluating the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease

The objectives of this trial are to assess the safety, tolerability and efficacy of A197 ophthalmic solution in comparison to a vehicle control in the treatment of subjects with Dry Eye Disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Aramis Site 113
    • California
      • Garden Grove, California, United States, 92843
        • Aramis Site 121
      • Glendale, California, United States, 95817
        • Aramis Site 120
      • Long Beach, California, United States, 90805
        • Aramis Site 106
      • Los Angeles, California, United States, 90013
        • Aramis Site 124
      • Murrieta, California, United States, 92562
        • Aramis Site 107
      • Newport Beach, California, United States, 92663
        • Aramis Site 102
      • Petaluma, California, United States, 94954
        • Aramis Site 116
      • Rancho Cordova, California, United States, 95670
        • Aramis Site 109
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Aramis Site 101
      • Jacksonville, Florida, United States, 32204
        • Aramis Site 112
      • Largo, Florida, United States, 33773
        • Aramis Site 117
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Aramis Site 118
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Aramis Site 114
      • Saint Louis, Missouri, United States, 63128
        • Aramis Site 111
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Aramis Site 108
    • North Carolina
      • Garner, North Carolina, United States, 27529
        • Aramis Site 110
      • Shelby, North Carolina, United States, 28150
        • Aramis Site 122
    • Ohio
      • Mason, Ohio, United States, 45040
        • Aramis Site 119
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Aramis Site 123
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Aramis Site 115
      • Memphis, Tennessee, United States, 38119
        • Aramis Site 103
    • Texas
      • Lakeway, Texas, United States, 78738
        • Aramis Site 104
      • San Antonio, Texas, United States, 78215
        • Aramis Site 105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Written informed consent must be obtained prior to any study-related assessments
  • Have a history of Dry Eye Disease in both eyes for at least 12 months prior to Visit 1
  • Willing and able to follow instructions and can be present for required study visits

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Use of topical ophthalmic medications, artificial tears, eye drops and gels in either eye
  • Use of contact lenses within 90 days prior to Visit 1 and throughout the study
  • Have had an ocular infection in either eye within 90 days prior to Visit 1

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Comparator
Drug: Active Comparator
Active Comparator
Experimental: A197 Ophthalmic Solution, High Dose
Drug: A197 Ophthalmic Solution
A197 Ophthalmic Solution
Experimental: A197 Ophthalmic Solution, Low Dose
Drug: A197 Ophthalmic Solution
A197 Ophthalmic Solution
Placebo Comparator: A197 Vehicle Control
Drug: A197 Vehicle Control
A197 Vehicle Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in total corneal fluorescein staining (CFS)
Time Frame: 12 Weeks
Corneal Fluorescein Staining (tCFS) is graded based on a modified National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 regions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-4 using 0.5 unit increments; 0 corresponds to no staining, 4 corresponds to maximum staining. The total score is the sum of the 5 regions ranging from 0-20.
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in eye dryness via the Visual Analogue Scale (VAS)
Time Frame: 12 Weeks
Eye dryness is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no symptoms and 100 to severe symptoms.
12 Weeks
Change from baseline in lissamine green conjunctival staining (LGCS)
Time Frame: 12 Weeks
Lissamine green conjunctival staining (LGCS) is graded based on the NEI Scale. The NEI scale divides the conjunctiva in 6 regions with the score for each region ranging from 0-3; 0 corresponds to no staining, 3 corresponds to maximum staining. The total score is the sum of the 6 regions ranging from 0-18.
12 Weeks
Change from baseline in bulbar conjunctival hyperemia (CCLRU)
Time Frame: 12 Weeks
Bulbar conjunctival hyperemia is graded based on the Cornea and Contact Lens Research Unit (CCLRU) grading scale where 0 corresponds to none, 4 corresponds to severe.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aramis Biosciences, Inc.

Investigators

  • Study Director: David S Tierney, MD, Aramis Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2022

Primary Completion (Actual)

January 24, 2023

Study Completion (Actual)

January 24, 2023

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

February 11, 2022

First Posted (Actual)

February 14, 2022

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A197-CS-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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