- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05360966
Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)
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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Antoinette Brown
- Phone Number: 949-526-8708
- Email: COMET-3@aeriepharma.com
Study Contact Backup
- Name: Helen Ameh
- Email: COMET-3@aeriepharma.com
Study Locations
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-
California
-
Chico, California, United States, 95926
- Reeve Woods Eye Center
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Fullerton, California, United States, 92835
- NVision Clinical Research - Fullerton
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La Mesa, California, United States, 91942
- NVision Clinical Research - La Mesa
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Newport Beach, California, United States, 92663
- Eye Research Foundation
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Northridge, California, United States, 91325
- Schultz Chang Vision
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Torrance, California, United States, 90505
- NVision Clinical Research - Torrance
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Florida
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Cape Coral, Florida, United States, 33904
- Argus Research Center
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Illinois
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Lake Villa, Illinois, United States, 60046
- Jacksoneye, S.C.
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Northbrook, Illinois, United States, 60062
- Wyse Eyecare
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Indiana
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Columbus, Indiana, United States, 47203
- Pankratz Eye Institute
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Massachusetts
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Andover, Massachusetts, United States, 01810
- Andover Eye Associates - Andover
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Milford, Massachusetts, United States, 01757
- Boston Vision
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Raynham, Massachusetts, United States, 02767
- Andover Eye Associates - Raynham
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Nevada
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Las Vegas, Nevada, United States, 89123
- AdvanceMed Clinical Research
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North Carolina
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Garner, North Carolina, United States, 27529
- Oculus Research
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Leland, North Carolina, United States, 28451
- Wilmington Eye
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Mint Hill, North Carolina, United States, 28227
- Pure Ophthalmic Research
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Pennsylvania
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Erie, Pennsylvania, United States, 16507
- Erie Retina Research
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Rhode Island
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Warwick, Rhode Island, United States, 02886
- Andover Eye Associates
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Texas
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Austin, Texas, United States, 78731
- Keystone Research
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Dallas, Texas, United States, 75243
- AXIS Clinicals
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Virginia
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Lynchburg, Virginia, United States, 24502
- Piedmont Eye Center
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Richmond, Virginia, United States, 23230
- Virginia Eye Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female, 30 years of age or older at the Screening visit
- Signs of DED at the Screening and Baseline visits assessed by corneal staining and Schirmer test
- Symptoms of DED at both Screening and Baseline visits assessed by SANDE questionnaire and ODS-VAS
- Corrected visual acuity (+0.70 LogMAR) or better in both eyes at both the Screening and Baseline visits
Exclusion Criteria:
- History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety
- Regular use of lid hygiene within 14 days prior to the Screening visit or any planned use during the study
- Use of artificial tears within 2 hours prior to the Screening visit or anticipated use during the study
- Use of any topical ocular anti-inflammatory medication within 30 days prior to the Screening visit or anticipated use during the study (e.g., ocular cyclosporine [Restasis®, Cequa™], lifitegrast [Xiidra®], or any other prescription ophthalmic product for DED, topical ocular corticosteroid- or non-steroidal-anti-inflammatory agents
- Use of Tyrvaya™ (varenicline solution, nasal spray 0.03mg) within 30 days prior to the Screening visit or anticipated use during the study
- Use of medications for the treatment of severe DED and/or Meibomian gland disease such as oral pilocarpine, oral cevimeline, oral macrolides, oral tetracyclines, oral tetracycline derivatives, and oral retinoids within 30 days prior to the Screening visit or anticipated use during the study.
- Initiation, discontinuation, or change in dose of a systemic medication known to cause ocular drying (e.g., antihistamines or tricyclic antidepressants) less than 14 days prior to the Screening visit or a change in dosage is anticipated during the study.
- Initiation, discontinuation, or change in dose of a systemic corticosteroid less than 60 days prior to the Screening visit or a change in dosage is anticipated during the study.
- Initiation, discontinuation, or change in dose of a systemic immunomodulator (e.g., hydroxychloroquine, methotrexate, cyclosporine) less than 60 days prior to the Screening visit or a change in dosage is anticipated during the study
- History or presence of significant systemic disease (i.e.: cardiovascular, pulmonary, hepatic, renal, hematologic, immunologic)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AR-15512 Ophthalmic Solution (0.003%)
0.003% AR-15512 to be administered BID for 90 days.
Both eyes will be treated.
|
Topical ocular administration of one drop in both eyes BID for 90 days.
|
Placebo Comparator: Vehicle
AR-15512 vehicle to be administered BID for 90 days.
Both eyes will be treated.
|
Topical ocular administration of one drop in both eyes BID for 90 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unanesthetized Schirmer test
Time Frame: Day 14
|
Proportion of subjects ≥ 10 mm increase in unanesthetized Schirmer score. Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over a 5-minute period, in whole millimeters to a maximum score of 35 mm. An ≥ 10 mm score over time indicates a better outcome. |
Day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SANDE (Symptom Assessment iN Dry Eye) Questionnaire Score
Time Frame: Day 28
|
Change from Baseline in SANDE score. The SANDE questionnaire consists of two visual analogue scales (VAS), each ranging from 0mm to 100mm to indicate the frequency (from "Rarely" to "All the Time") and severity (from "Very Mild" to "Very Severe") of dry eye symptoms. A higher score indicates greater frequency or severity. Each subject marks both VAS to indicate their level of frequency and severity. The SANDE score is calculated by multiplying the frequency score by the severity score and obtaining the square root. A reduced SANDE score over time indicates a better outcome. |
Day 28
|
SANDE (Symptom Assessment iN Dry Eye) Questionnaire Score
Time Frame: Day 7, 14, 90
|
Change from Baseline in SANDE score. The SANDE questionnaire consists of two visual analogue scales (VAS), each ranging from 0mm to 100mm to indicate the frequency (from "Rarely" to "All the Time") and severity (from "Very Mild" to "Very Severe") of dry eye symptoms. A higher score indicates greater frequency or severity. Each subject marks both VAS to indicate their level of frequency and severity. The SANDE score is calculated by multiplying the frequency score by the severity score and obtaining the square root. A reduced SANDE score over time indicates a better outcome. |
Day 7, 14, 90
|
Unanesthetized Schirmer score
Time Frame: Day 7, 14, 28 & 90
|
Change from Baseline Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over a 5-minute period, in whole millimeters to a maximum score of 35 mm. An increased score over time indicates a better outcome. |
Day 7, 14, 28 & 90
|
Ocular Discomfort Score (ODS) - VAS
Time Frame: Day 28 & 90
|
Change from Baseline Subjects mark a visual analogue scale (VAS) between 0mm to 100mm to indicate (from "no symptom" to "maximal symptom") their ocular discomfort. A reduced score over time indicates a better outcome. |
Day 28 & 90
|
Eye Dryness Score (EDS) - VAS
Time Frame: Day 28 & 90
|
Change from Baseline Subjects mark a visual analogue scale (VAS) between 0mm to 100mm to indicate (from "no symptom" to "maximal symptom") their eye dryness. A reduced score over time indicates a better outcome. |
Day 28 & 90
|
Unanesthetized Schirmer score
Time Frame: Day 7, 28 & 90
|
Proportion of subjects with ≥ 10 mm increase in score Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over a 5-minute period, in whole millimeters to a maximum score of 35 mm. An ≥ 10 mm score over time indicates a better outcome. |
Day 7, 28 & 90
|
Quality of Life VAS
Time Frame: Day 7, 14, 28 & 90
|
Change from Baseline Subjects mark a visual analogue scale (VAS) between 0mm to 100mm to indicate (from "strongly disagree" to "strongly agree") their agreement with the statement "Over the past 3 days my dry eye has interfered with my daily activities and reduced my quality of life". A reduced score over time indicates a better outcome. |
Day 7, 14, 28 & 90
|
Ocular Pain - VAS
Time Frame: Day 90
|
Change from Baseline Subjects mark a visual analogue scale (VAS) between 0mm to 100mm to indicate (from "no symptom" to "maximal symptom") their ocular discomfort. A reduced score over time indicates a better outcome. |
Day 90
|
Conjunctival Redness
Time Frame: Day 90
|
Change from Baseline Investigators or designated sub-Investigators grade redness of the eye on a scale from 0 to 4 (from 0 "normal" to 4 "severe"). A reduced score over time indicates a better outcome. |
Day 90
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Michelle Senchyna, PhD, Aerie Pharmaceuticals
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AR-15512-CS302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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