Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)
Public ClinicalTrials.gov record NCT05360966. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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-3)
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
- NCT05360966
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 467 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
- Jul 18, 2022 (Actual)
- Primary completion
- Oct 17, 2023 (Actual)
- Completion
- Oct 17, 2023 (Actual)
- Last update posted
- Jul 23, 2025
2022 – 2023
United States locations
- U.S. sites
- 23
- U.S. states
- 12
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Reeve Woods Eye Center | Chico | California | 95926 | — |
| NVision Clinical Research, LLC | Fullerton | California | 92835 | — |
| Eye Research Foundation | Newport Beach | California | 92663 | — |
| Shultz Vision | Northridge | California | 91325 | — |
| NVision Clinical Research, LLC | Torrance | California | 90505 | — |
| Argus Research Center | Cape Coral | Florida | 33904 | — |
| Jackson Eye | Lake Villa | Illinois | 60046 | — |
| Wyse Eyecare | Northbrook | Illinois | 60062 | — |
| Pankratz Eye Institute | Columbus | Indiana | 47203 | — |
| Andover Eye Associates | Andover | Massachusetts | 01810 | — |
| Boston Vision | Milford | Massachusetts | 01757 | — |
| Andover Eye Associates - Raynham | Raynham | Massachusetts | 02767 | — |
| AdvanceMed Clinical Research | Las Vegas | Nevada | 89123 | — |
| NVision Clinical Research, LLC | Rochester | New York | 14624 | — |
| Oculus Research | Garner | North Carolina | 27529 | — |
| Wilmington Eye | Leland | North Carolina | 28451 | — |
| Pure Ophthalmic Research | Mint Hill | North Carolina | 28227 | — |
| Erie Retina Research | Erie | Pennsylvania | 16507 | — |
| Andover Eye Associates | Warwick | Rhode Island | 02886 | — |
| Keystone Research | Austin | Texas | 78731 | — |
| Axis Clinicals | Dallas | Texas | 75243 | — |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | — |
| Virginia Eye Institute | Richmond | Virginia | 23230 | — |
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 NCT05360966, 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 Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05360966 live on ClinicalTrials.gov.