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Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)

Primary Purpose

Dry Eye Disease

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AR-15512 Ophthalmic Solution
Vehicle
Sponsored by
Aerie Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Reeve Woods Eye Center
  • NVision Clinical Research - Fullerton
  • NVision Clinical Research - La Mesa
  • Eye Research Foundation
  • Schultz Chang Vision
  • NVision Clinical Research - Torrance
  • Argus Research Center
  • Jacksoneye, S.C.
  • Wyse Eyecare
  • Pankratz Eye Institute
  • Andover Eye Associates - Andover
  • Boston Vision
  • Andover Eye Associates - Raynham
  • AdvanceMed Clinical Research
  • Oculus Research
  • Wilmington Eye
  • Pure Ophthalmic Research
  • Erie Retina Research
  • Andover Eye Associates
  • Keystone Research
  • Axis Clinicals
  • Piedmont Eye Center
  • Virginia Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AR-15512 Ophthalmic Solution (0.003%)

Vehicle

Arm Description

0.003% AR-15512 to be administered BID for 90 days. Both eyes will be treated.

AR-15512 vehicle to be administered BID for 90 days. Both eyes will be treated.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 2, 2022
Last Updated
August 25, 2023
Sponsor
Aerie Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05360966
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerie Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
During the randomized treatment period, the investigator and site staff performing eligibility / efficacy and safety assessments and the subjects will be masked.
Allocation
Randomized
Enrollment
467 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AR-15512 Ophthalmic Solution (0.003%)
Arm Type
Experimental
Arm Description
0.003% AR-15512 to be administered BID for 90 days. Both eyes will be treated.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
AR-15512 vehicle to be administered BID for 90 days. Both eyes will be treated.
Intervention Type
Drug
Intervention Name(s)
AR-15512 Ophthalmic Solution
Intervention Description
Topical ocular administration of one drop in both eyes BID for 90 days.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Topical ocular administration of one drop in both eyes BID for 90 days.
Primary Outcome Measure Information:
Title
Unanesthetized Schirmer test
Description
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.
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
SANDE (Symptom Assessment iN Dry Eye) Questionnaire Score
Description
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.
Time Frame
Day 28
Title
SANDE (Symptom Assessment iN Dry Eye) Questionnaire Score
Description
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.
Time Frame
Day 7, 14, 90
Title
Unanesthetized Schirmer score
Description
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.
Time Frame
Day 7, 14, 28 & 90
Title
Ocular Discomfort Score (ODS) - VAS
Description
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.
Time Frame
Day 28 & 90
Title
Eye Dryness Score (EDS) - VAS
Description
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.
Time Frame
Day 28 & 90
Title
Unanesthetized Schirmer score
Description
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.
Time Frame
Day 7, 28 & 90
Title
Quality of Life VAS
Description
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.
Time Frame
Day 7, 14, 28 & 90
Title
Ocular Pain - VAS
Description
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.
Time Frame
Day 90
Title
Conjunctival Redness
Description
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.
Time Frame
Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Senchyna, PhD
Organizational Affiliation
Aerie Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Reeve Woods Eye Center
City
Chico
State/Province
California
ZIP/Postal Code
95926
Country
United States
Facility Name
NVision Clinical Research - Fullerton
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
NVision Clinical Research - La Mesa
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Schultz Chang Vision
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
NVision Clinical Research - Torrance
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Argus Research Center
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33904
Country
United States
Facility Name
Jacksoneye, S.C.
City
Lake Villa
State/Province
Illinois
ZIP/Postal Code
60046
Country
United States
Facility Name
Wyse Eyecare
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Pankratz Eye Institute
City
Columbus
State/Province
Indiana
ZIP/Postal Code
47203
Country
United States
Facility Name
Andover Eye Associates - Andover
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Boston Vision
City
Milford
State/Province
Massachusetts
ZIP/Postal Code
01757
Country
United States
Facility Name
Andover Eye Associates - Raynham
City
Raynham
State/Province
Massachusetts
ZIP/Postal Code
02767
Country
United States
Facility Name
AdvanceMed Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Oculus Research
City
Garner
State/Province
North Carolina
ZIP/Postal Code
27529
Country
United States
Facility Name
Wilmington Eye
City
Leland
State/Province
North Carolina
ZIP/Postal Code
28451
Country
United States
Facility Name
Pure Ophthalmic Research
City
Mint Hill
State/Province
North Carolina
ZIP/Postal Code
28227
Country
United States
Facility Name
Erie Retina Research
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507
Country
United States
Facility Name
Andover Eye Associates
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Keystone Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Axis Clinicals
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Piedmont Eye Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Virginia Eye Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)

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