Clinical trial NCT05360966: Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-05-04
Enrollment: 467
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Qualified subjects will be enrolled in the study and randomized in a 1:1 ratio within each site to receive 0.003% AR 15512 or AR-15512 vehicle to be administered twice daily (BID) as 1 drop in each eye for 90 days.
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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)

Primary outcomes:
measure: Unanesthetized Schirmer test
timeFrame: Day 14
Secondary outcomes:
measure: SANDE (Symptom Assessment iN Dry Eye) Questionnaire Score
timeFrame: Day 28
measure: SANDE (Symptom Assessment iN Dry Eye) Questionnaire Score
timeFrame: Day 7, 14, 90
measure: Unanesthetized Schirmer score
timeFrame: Day 7, 14, 28 & 90
measure: Ocular Discomfort Score (ODS) - VAS
timeFrame: Day 28 & 90
measure: Eye Dryness Score (EDS) - VAS
timeFrame: Day 28 & 90
measure: Unanesthetized Schirmer score
timeFrame: Day 7, 28 & 90
measure: Quality of Life VAS
timeFrame: Day 7, 14, 28 & 90
measure: Ocular Pain - VAS
timeFrame: Day 90
measure: Conjunctival Redness
timeFrame: Day 90
Other outcomes:
Locations:
city: Chico
country: United States
facility: Reeve Woods Eye Center
state: California
city: Fullerton
country: United States
facility: NVision Clinical Research - Fullerton
state: California
city: La Mesa
country: United States
facility: NVision Clinical Research - La Mesa
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Northridge
country: United States
facility: Schultz Chang Vision
state: California
city: Torrance
country: United States
facility: NVision Clinical Research - Torrance
state: California
city: Cape Coral
country: United States
facility: Argus Research Center
state: Florida
city: Lake Villa
country: United States
facility: Jacksoneye, S.C.
state: Illinois
city: Northbrook
country: United States
facility: Wyse Eyecare
state: Illinois
city: Columbus
country: United States
facility: Pankratz Eye Institute
state: Indiana
city: Andover
country: United States
facility: Andover Eye Associates - Andover
state: Massachusetts
city: Milford
country: United States
facility: Boston Vision
state: Massachusetts
city: Raynham
country: United States
facility: Andover Eye Associates - Raynham
state: Massachusetts
city: Las Vegas
country: United States
facility: AdvanceMed Clinical Research
state: Nevada
city: Garner
country: United States
facility: Oculus Research
state: North Carolina
city: Leland
country: United States
facility: Wilmington Eye
state: North Carolina
city: Mint Hill
country: United States
facility: Pure Ophthalmic Research
state: North Carolina
city: Erie
country: United States
facility: Erie Retina Research
state: Pennsylvania
city: Warwick
country: United States
facility: Andover Eye Associates
state: Rhode Island
city: Austin
country: United States
facility: Keystone Research
state: Texas
city: Dallas
country: United States
facility: Axis Clinicals
state: Texas
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Eye Institute
state: Virginia
Study officials:
affiliation: Aerie Pharmaceuticals
name: Michelle Senchyna, PhD
role: STUDY_DIRECTOR
References: