Clinical trial NCT05285644: Study Evaluating the Safety and Efficacy of AR-15512
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-2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-03-17
Enrollment: 465
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 solution 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 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: Glendale
country: United States
facility: Global Research Management, Inc
state: California
city: Torrance
country: United States
facility: Premiere Practice Management, LLC
state: California
city: Colorado Springs
country: United States
facility: Vision Institute
state: Colorado
city: Waterbury
country: United States
facility: The Eye Care Group
state: Connecticut
city: Delray Beach
country: United States
facility: Segal Drug Trials, Inc.
state: Florida
city: Indianapolis
country: United States
facility: Michael Washburn Center for Ophthalmic Research, LLC
state: Indiana
city: Louisville
country: United States
facility: Butchertown Clinical Trials
state: Kentucky
city: Lewiston
country: United States
facility: Central Maine Eye Care
state: Maine
city: Kansas City
country: United States
facility: Moyes Eye Center
state: Missouri
city: Henderson
country: United States
facility: Center for Sight
state: Nevada
city: Shelby
country: United States
facility: Core, Inc.
state: North Carolina
city: Fargo
country: United States
facility: Bergstrom Eye Research
state: North Dakota
city: Eugene
country: United States
facility: Verum Research
state: Oregon
city: Erie
country: United States
facility: Erie Retina Surgery
state: Pennsylvania
city: Goodlettsville
country: United States
facility: Advancing Vision Research
state: Tennessee
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Smyrna
country: United States
facility: Advancing Vision Research
state: Tennessee
city: Austin
country: United States
facility: Austin Clinical Research
state: Texas
city: Harlingen
country: United States
facility: Valley Retina Institute, PA
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute, PA
state: Texas
city: San Antonio
country: United States
facility: Eye Clinics of South Texas
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research, LLC
state: Texas
city: Clinton
country: United States
facility: Alpine Research Organization Inc.
state: Utah
Study officials:
affiliation: Aerie Pharmaceuticals
name: Michelle Senchyna, PhD
role: STUDY_DIRECTOR
References: