A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512
Public ClinicalTrials.gov record NCT05493111. 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 Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512, a Cold Thermoreceptor Modulator, for the Treatment of Dry Eye Disease (COMET-4)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the safety of topical ophthalmic 0.003% AR-15512 compared to its vehicle dosed twice daily (BID) in subjects with dry eye disease (DED) for 12 months.
Study identification
- NCT ID
- NCT05493111
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 275 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 18 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
- Oct 31, 2022
- Primary completion
- Feb 27, 2024
- Completion
- Feb 27, 2024
- Last update posted
- Aug 12, 2025
2022 – 2024
United States locations
- U.S. sites
- 10
- U.S. states
- 6
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Eye Center | Chandler | Arizona | 85225 | — |
| Arizona Eye Institute | Sun City | Arizona | 85351 | — |
| Global Research Management | Glendale | California | 91204 | — |
| Macy Eye Center | Los Angeles | California | 90048 | — |
| Eye Research Foundation | Newport Beach | California | 92663 | — |
| Shultz Vision | Northridge | California | 91325 | — |
| SightMD | Manhasset | New York | 11030 | — |
| University Eye Specialists | Maryville | Tennessee | 37803 | — |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | — |
| Periman Eye Institute | Seattle | Washington | 98119 | — |
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 NCT05493111, 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 Aug 12, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05493111 live on ClinicalTrials.gov.