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

Completed · Phase 2

Conditions studied: Dry Eye Disease

In brief

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.

Key facts

Study ID

NCT05238597

Run by

Aramis Biosciences, Inc.

People needed

207

Starts

2022-01-25

Expected to finish

2023-01-24

Last updated by the study team

2023-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Aramis Site 113 — Birmingham, Alabama, United States
• Aramis Site 121 — Garden Grove, California, United States
• Aramis Site 120 — Glendale, California, United States
• Aramis Site 106 — Long Beach, California, United States
• Aramis Site 124 — Los Angeles, California, United States
• Aramis Site 107 — Murrieta, California, United States
• Aramis Site 102 — Newport Beach, California, United States
• Aramis Site 116 — Petaluma, California, United States
• Aramis Site 109 — Rancho Cordova, California, United States
• Aramis Site 101 — Delray Beach, Florida, United States
• Aramis Site 112 — Jacksonville, Florida, United States
• Aramis Site 117 — Largo, Florida, United States
• Aramis Site 118 — Edgewood, Kentucky, United States
• Aramis Site 114 — Kansas City, Missouri, United States
• Aramis Site 111 — St Louis, Missouri, United States
• Aramis Site 108 — Las Vegas, Nevada, United States
• Aramis Site 110 — Garner, North Carolina, United States
• Aramis Site 122 — Shelby, North Carolina, United States
• Aramis Site 119 — Mason, Ohio, United States
• Aramis Site 123 — Cranberry Township, Pennsylvania, United States
• Aramis Site 115 — Goodlettsville, Tennessee, United States
• Aramis Site 103 — Memphis, Tennessee, United States
• Aramis Site 104 — Lakeway, Texas, United States
• Aramis Site 105 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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