Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease
Lead Sponsor:
Aramis Biosciences, Inc.
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2023
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT05238597
Start Date
January 25 2022
End Date
January 24 2023
Last Update
May 16 2023
Active Locations (24)
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1
Aramis Site 113
Birmingham, Alabama, United States, 35233
2
Aramis Site 121
Garden Grove, California, United States, 92843
3
Aramis Site 120
Glendale, California, United States, 95817
4
Aramis Site 106
Long Beach, California, United States, 90805