A Study to Evaluate the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease
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
1 other identifier
interventional
207
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2022
Shorter than P25 for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 25, 2022
CompletedFirst Submitted
Initial submission to the registry
February 3, 2022
CompletedFirst Posted
Study publicly available on registry
February 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2023
CompletedMay 16, 2023
May 1, 2023
12 months
February 3, 2022
May 15, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in total corneal fluorescein staining (CFS)
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 Outcomes (3)
Change from baseline in eye dryness via the Visual Analogue Scale (VAS)
12 Weeks
Change from baseline in lissamine green conjunctival staining (LGCS)
12 Weeks
Change from baseline in bulbar conjunctival hyperemia (CCLRU)
12 Weeks
Study Arms (4)
A197 Ophthalmic Solution, High Dose
EXPERIMENTALA197 Ophthalmic Solution, Low Dose
EXPERIMENTALA197 Vehicle Control
PLACEBO COMPARATORActive Comparator
ACTIVE COMPARATORInterventions
A197 Ophthalmic Solution
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Aramis Site 113
Birmingham, Alabama, 35233, United States
Aramis Site 121
Garden Grove, California, 92843, United States
Aramis Site 120
Glendale, California, 95817, United States
Aramis Site 106
Long Beach, California, 90805, United States
Aramis Site 124
Los Angeles, California, 90013, United States
Aramis Site 107
Murrieta, California, 92562, United States
Aramis Site 102
Newport Beach, California, 92663, United States
Aramis Site 116
Petaluma, California, 94954, United States
Aramis Site 109
Rancho Cordova, California, 95670, United States
Aramis Site 101
Delray Beach, Florida, 33484, United States
Aramis Site 112
Jacksonville, Florida, 32204, United States
Aramis Site 117
Largo, Florida, 33773, United States
Aramis Site 118
Edgewood, Kentucky, 41017, United States
Aramis Site 114
Kansas City, Missouri, 64111, United States
Aramis Site 111
St Louis, Missouri, 63128, United States
Aramis Site 108
Las Vegas, Nevada, 89119, United States
Aramis Site 110
Garner, North Carolina, 27529, United States
Aramis Site 122
Shelby, North Carolina, 28150, United States
Aramis Site 119
Mason, Ohio, 45040, United States
Aramis Site 123
Cranberry Township, Pennsylvania, 16066, United States
Aramis Site 115
Goodlettsville, Tennessee, 37072, United States
Aramis Site 103
Memphis, Tennessee, 38119, United States
Aramis Site 104
Lakeway, Texas, 78738, United States
Aramis Site 105
San Antonio, Texas, 78215, United States
Related Publications (1)
Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.
PMID: 36729473DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David S Tierney, MD
Aramis Biosciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2022
First Posted
February 14, 2022
Study Start
January 25, 2022
Primary Completion
January 24, 2023
Study Completion
January 24, 2023
Last Updated
May 16, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share