Study Evaluating the Safety and Efficacy of AR-15512
Public ClinicalTrials.gov record NCT05285644. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Phase 3 Study Evaluating the Safety and Efficacy of AR-15512, a Cold Thermoreceptor Modulator, for the Treatment of Dry Eye Disease (COMET-2)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This will be a Phase 3, multicenter, vehicle-controlled, double-masked, randomized study conducted at approximately 20 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of Screening (Day -14) and Baseline (Day 1) visits as well as visits at Day 7, Day 14, Day 28, and Day 90 (Study Exit) for an individual duration of participation of approximately 15 weeks.
Study identification
- NCT ID
- NCT05285644
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 465 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 30 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 9, 2022 (Actual)
- Primary completion
- Jul 24, 2023 (Actual)
- Completion
- Jul 24, 2023 (Actual)
- Last update posted
- Jul 23, 2025
2022 – 2023
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Global Research Management, Inc | Glendale | California | 90027 | — |
| Premiere Practice Management, LLC | Torrance | California | 90505 | — |
| Vision Institute | Colorado Springs | Colorado | 80907 | — |
| The Eye Care Group | Waterbury | Connecticut | 06708 | — |
| Segal Drug Trials, Inc. | Delray Beach | Florida | 33484 | — |
| Michael Washburn Center for Ophthalmic Research, LLC | Indianapolis | Indiana | 46240 | — |
| Butchertown Clinical Trials | Louisville | Kentucky | 40206 | — |
| Central Maine Eye Care | Lewiston | Maine | 04240 | — |
| Moyes Eye Center | Kansas City | Missouri | 64154 | — |
| Center for Sight | Henderson | Nevada | 89052 | — |
| Core, Inc. | Shelby | North Carolina | 28150 | — |
| Bergstrom Eye Research | Fargo | North Dakota | 58103 | — |
| Verum Research | Eugene | Oregon | 97401 | — |
| Erie Retina Research | Erie | Pennsylvania | 16507 | — |
| Advancing Vision Research | Goodlettsville | Tennessee | 37072 | — |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | — |
| Advancing Vision Research | Smyrna | Tennessee | 37167 | — |
| Austin Clinical Research | Austin | Texas | 78750 | — |
| Valley Retina Institute, PA | Harlingen | Texas | 78550 | — |
| Valley Retina Institute, PA | McAllen | Texas | 78503 | — |
| Eye Clinics of South Texas | San Antonio | Texas | 78209 | — |
| R and R Eye Research, LLC | San Antonio | Texas | 78229 | — |
| Alpine Research Organization Inc. | Clinton | Utah | 84015 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05285644, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 23, 2025 · Synced Nov 7, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05285644 live on ClinicalTrials.gov.