Clinical trial NCT05493111: A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-08-09
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a Phase 3, 12-month, multicenter, vehicle-controlled, double-masked, randomized Phase 3 study conducted at approximately 10 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of a Baseline Visit (Day 1) as well as visits on Days 14, Day 90, Day 180, Day 270, and Day 365 (Study Exit). In addition, there will be dispensing visits on Days 45, 135, 225, and 315.

Detailed description: At the end of the Screening Visit, subjects will undergo a protocol-specified washout period for prohibited prior and concomitant therapies. At the Baseline Visit, subjects who qualify based on inclusion/exclusion criteria will be enrolled in the study and randomized in a 2:1 ratio to receive 0.003% AR-15512 or AR-15512 Vehicle administered as 1 drop in each eye twice a day for 365 days (12 months). At the end of the Day 365 visit, subjects will exit the study.

Aerie Pharmaceuticals was acquired by Alcon on November 22, 2022.

Eligibility criteria: Key Inclusion Criteria:

* Previous history of Dry Eye Disease (DED) within the previous 12 months of the Baseline visit.
* Have used or desired to use artificial tears for DED symptoms within 3 months prior to the Baseline visit.
* Schirmer test score with or without topical anesthesia as specified in the protocol within 1 year of the Baseline visit.
* Total ocular surface staining score as specified in the protocol at the Baseline visit.
* Corrected visual acuity as specified in the protocol at the Baseline visit.
* Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history, and vital signs (heart rate and blood pressure) at the Baseline visit.

Key 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.
* Current evidence of other significant ophthalmic disease requiring topical medication (e.g. glaucoma, ocular hypertension) which may interfere with vision (e.g., cataract, macular degeneration) or other disease which the investigator believes may interfere with study findings or interpretation.
* Use of contact lenses in either eye within 7 days prior to the Baseline visit or planned use during the study.
* Use of medications as specified in the protocol.
* Use of lid heating therapy (i.e., LipiFlow®, iLUX®) or Meibomian gland probing/therapeutic expression within 6 months prior to the Baseline visit or anticipated during the study.

Primary outcomes:
measure: Adverse Events
timeFrame: Day 1, 14, 90, 180, 270 & 365
measure: Blood Pressure
timeFrame: Day 1, 14, 90, 180, 270 & 365
measure: Heart Rate
timeFrame: Time Frame: Day 1, 14, 90, 180, 270 & 365
measure: Endothelial cell counts
timeFrame: Day 1 and 365
measure: Hematology, chemistry, and urinalysis
timeFrame: Day 1, 180 & 365
measure: LogMAR Visual Acuity
timeFrame: Day 1, 14, 90, 180, 270 & 365
measure: Early Treatment of Diabetic Retinopathy Study (ETDRS) Visual Acuity
timeFrame: Day 1 & 365
measure: Biomicroscopy
timeFrame: Day 1, 14, 90, 180, 270 & 365
measure: Total ocular staining
timeFrame: Day 1, 14, 90, 180, 270 & 365
measure: Intraocular pressure (IOP)
timeFrame: Day 1, 14, 90, 180, 270 & 365
measure: Dilated fundus exam
timeFrame: Day 1, 14, 90, 180, 270 & 365
Secondary outcomes:
Other outcomes:
measure: Minimum Plasma Concentration (Cmin)
timeFrame: Day 1, 14 and 90
measure: Accumulation Ratio (Rcmax)
timeFrame: Day 1, 14 and 90
measure: Time to Maximum Concentration (Tmax)
timeFrame: Day 1, 14 and 90
measure: Time to Last Detectable Concentration (Tlast)
timeFrame: Day 1, 14 and 90
measure: Total Exposure (AUC0-last)
timeFrame: Day 1, 14 and 90
Locations:
city: Chandler
country: United States
facility: Arizona Eye Center
state: Arizona
city: Sun City
country: United States
facility: Arizona Eye Institute
state: Arizona
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Los Angeles
country: United States
facility: Macy Eye Center
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Northridge
country: United States
facility: Shultz Vision
state: California
city: Manhasset
country: United States
facility: SightMD
state: New York
city: Maryville
country: United States
facility: University Eye Specialists
state: Tennessee
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Seattle
country: United States
facility: Periman Eye Institute
state: Washington
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Fellow, Clinical Research
role: STUDY_DIRECTOR
References: