Study Evaluating the Safety and Efficacy of AR-15512

Dry Eye Disease Clinical Trial

— COMET-2  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05285644
• Other study ID #: AR-15512-CS301
• Status: Completed
• Phase: Phase 3
• Start date: May 9, 2022
• Est. completion date: July 21, 2023

Study information

• Verified date: August 2023
• Source: Aerie Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: July 21, 2023
• Est. primary completion date: July 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• AR 15512 Ophthalmic Solution
Topical ocular administration of one drop in both eyes BID for 90 days.
• Vehicle
Topical ocular administration of one drop in both eyes BID for 90 days.

Locations

Country	Name	City	State
United States	Austin Clinical Research	Austin	Texas
United States	Alpine Research Organization Inc.	Clinton	Utah
United States	Vision Institute	Colorado Springs	Colorado
United States	Segal Drug Trials, Inc.	Delray Beach	Florida
United States	Erie Retina Surgery	Erie	Pennsylvania
United States	Verum Research	Eugene	Oregon
United States	Bergstrom Eye Research	Fargo	North Dakota
United States	Global Research Management, Inc	Glendale	California
United States	Advancing Vision Research	Goodlettsville	Tennessee
United States	Valley Retina Institute, PA	Harlingen	Texas
United States	Center for Sight	Henderson	Nevada
United States	Michael Washburn Center for Ophthalmic Research, LLC	Indianapolis	Indiana
United States	Moyes Eye Center	Kansas City	Missouri
United States	Central Maine Eye Care	Lewiston	Maine
United States	Butchertown Clinical Trials	Louisville	Kentucky
United States	Valley Retina Institute, PA	McAllen	Texas
United States	Total Eye Care, PA	Memphis	Tennessee
United States	Eye Clinics of South Texas	San Antonio	Texas
United States	R and R Eye Research, LLC	San Antonio	Texas
United States	Core, Inc.	Shelby	North Carolina
United States	Advancing Vision Research	Smyrna	Tennessee
United States	Premiere Practice Management, LLC	Torrance	California
United States	The Eye Care Group	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unanesthetized Schirmer test	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	SANDE (Symptom Assessment iN Dry Eye) Questionnaire Score	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
Secondary	SANDE (Symptom Assessment iN Dry Eye) Questionnaire Score	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
Secondary	Unanesthetized Schirmer score	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
Secondary	Ocular Discomfort Score (ODS) - VAS	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
Secondary	Eye Dryness Score (EDS) - VAS	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
Secondary	Unanesthetized Schirmer score	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
Secondary	Quality of Life VAS	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
Secondary	Ocular Pain - VAS	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
Secondary	Conjunctival Redness	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