A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease
Public ClinicalTrials.gov record NCT04498182. 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 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease (COMET-1)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 2b, multicenter, vehicle-controlled, double-masked, randomized study. All subjects enrolled will have dry eye disease. The study consists of Screening and Baseline visits to determine eligibility, followed by efficacy assessments at Day 14 (Visit 3), 28 (Visit 4) and 84 (Visit 5/Study Exit). Safety will be assessed at all study visits.
Study identification
- NCT ID
- NCT04498182
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 369 participants
Conditions and interventions
Conditions
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
- Oct 26, 2020 (Actual)
- Primary completion
- Jul 17, 2021 (Actual)
- Completion
- Jul 17, 2021 (Actual)
- Last update posted
- Aug 28, 2024
2020 – 2021
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cornea and Cataract Consultants of Arizona | Phoenix | Arizona | 85032 | — |
| Eye Research Foundation | Newport Beach | California | 92663 | — |
| Vision Institute | Colorado Springs | Colorado | 80907 | — |
| Midwest Cornea Associates, LLC | Carmel | Indiana | 46290 | — |
| Michael Washburn Center for Ophthalmic Research, LLC | Indianapolis | Indiana | 46240 | — |
| The Eye Care Institute | Louisville | Kentucky | 40206 | — |
| Andover Eye Associates | Andover | Massachusetts | 01810 | — |
| Andover Eye Associates | Raynham | Massachusetts | 02767 | — |
| Complete Eye Care of Medina | Hamel | Minnesota | 55340 | — |
| Moyes Eye Center | Kansas City | Missouri | 64154 | — |
| Vita Eye Clinic | Shelby | North Carolina | 28150 | — |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | — |
| Advancing Vision Research, LLC | Smyrna | Tennessee | 37167 | — |
| Alpine Research Organization, Inc, | Clinton | Utah | 84015 | — |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | — |
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 NCT04498182, 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 28, 2024 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04498182 live on ClinicalTrials.gov.