A Study to Evaluate the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease
NCT ID: NCT05238597
Last Updated: 2023-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
207 participants
INTERVENTIONAL
2022-01-25
2023-01-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Trial to Assess Subjects With Dry Eye Disease.
NCT04971031
A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease
NCT04498182
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease
NCT04735393
A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
NCT01468168
A Multi-Center Study Subjects With Dry Eye Syndrome
NCT01745887
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A197 Ophthalmic Solution, High Dose
A197 Ophthalmic Solution
A197 Ophthalmic Solution
A197 Ophthalmic Solution, Low Dose
A197 Ophthalmic Solution
A197 Ophthalmic Solution
A197 Vehicle Control
A197 Vehicle Control
A197 Vehicle Control
Active Comparator
Active Comparator
Active Comparator
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
A197 Ophthalmic Solution
A197 Ophthalmic Solution
A197 Vehicle Control
A197 Vehicle Control
Active Comparator
Active Comparator
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aramis Biosciences, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David S Tierney, MD
Role: STUDY_DIRECTOR
Aramis Biosciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A197-CS-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.