A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease (COMET-1)

A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease (COMET-1)

This is a Phase 2b, multicenter, vehicle-controlled, double-masked, randomized study. All subjects enrolled will have dry eye disease. The study consists of Screening and Baseline visits to determine eligibility, followed by efficacy assessments at Day 14 (Visit 3), 28 (Visit 4) and 84 (Visit 5/Study Exit). Safety will be assessed at all study visits.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: AR-15512 Ophthalmic Solution; Drug: AR-15512 Ophthalmic Solution Vehicle

Detailed Description

At the end of the Screening Visit, all qualified subjects will be assigned to administer AR-15512 vehicle twice a day to both eyes for 14 days (vehicle run-in period). After the vehicle run-in period, subjects will be re-evaluated for signs and symptoms of Dry Eye Disease (DED). Subjects who requalify based on inclusion/exclusion criteria will be randomized in a 1:1:1 ratio to receive AR-15512 0.0014% (lower dose), AR-15512 0.003% (higher dose) or AR-15512 vehicle administered as 1 drop in each eye twice daily for 84 days.

This study will utilize a Controlled Adverse Environment (CAE) chamber, which serves to (1) minimize the factors that could impact the evaluation (temperature, humidity, and airflow) and (2) stress the ocular surface in a safe, standardized, controlled, and reproducible manner. Subjects will be exposed to the CAE for approximately 90 minutes during each CAE visit. Subjects will be exposed to the CAE at the Screening and Baseline visits as well as on Day 28 (Visit 4) and Day 84 (Visit 5). Efficacy endpoints will be evaluated pre- and post- exposure to the CAE.

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

• Study Type: Interventional
• Enrollment (Actual): 369
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Cornea and Cataract Consultants of Arizona
  • California
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Vision Institute
  • Indiana
    • Carmel, Indiana, United States, 46290
      • Midwest Cornea Associates, LLC
    • Indianapolis, Indiana, United States, 46240
      • Michael Washburn Center for Ophthalmic Research, LLC
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • The Eye Care Institute
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates
    • Raynham, Massachusetts, United States, 02767
      • Andover Eye Associates
  • Minnesota
    • Hamel, Minnesota, United States, 55340
      • Complete Eye Care of Medina
  • Missouri
    • Kansas City, Missouri, United States, 64154
      • Moyes Eye Center
  • North Carolina
    • Shelby, North Carolina, United States, 28150
      • Vita Eye Clinic
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, PA
    • Smyrna, Tennessee, United States, 37167
      • Advancing Vision Research, LLC
  • Utah
    • Clinton, Utah, United States, 84015
      • Alpine Research Organization, Inc,
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Piedmont Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Previous history of dry eye disease (DED) within the previous 6 months;
• Have used and/or desired to use artificial tears for DED symptoms within 2 months prior to the Screening visit;
• Signs and symptoms of DED at the Screening and Baseline visits;
• Best Corrected Visual Acuity (BCVA) of 20/200 (+0.70 LogMAR) or better in both eyes at both the Screening and Baseline visits;
• Other protocol-specified inclusion criteria may apply.

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 diseases which, in the opinion of the investigator, may interfere with study findings or interpretation;
• Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study;
• Regular use of ocular medications or nutritional supplements as specified in the protocol within 30 days prior to the Screening visit;
• Positive pregnancy test at Screening or Baseline visits or currently breastfeeding.
• Other protocol-specified exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AR-15512 Ophthalmic Solution Higher Dose; AR-15512 Ophthalmic Solution 0.003%, one drop in each eye twice daily for 84 days. Both eyes will be treated.	Drug: AR-15512 Ophthalmic Solution; Ophthalmic solution administered via topical ocular instillation in one of two dose concentrations: 0.0014% (lower dose) or 0.003% (higher dose)
Experimental: AR-15512 Ophthalmic Solution Lower Dose; AR-15512 Ophthalmic Solution 0.0014%, one drop in each eye twice daily for 84 days. Both eyes will be treated.	Drug: AR-15512 Ophthalmic Solution; Ophthalmic solution administered via topical ocular instillation in one of two dose concentrations: 0.0014% (lower dose) or 0.003% (higher dose)
Placebo Comparator: Vehicle; AR-15512 Ophthalmic Solution Vehicle, one drop in each eye twice daily for 84 days. Both eyes will be treated.	Drug: AR-15512 Ophthalmic Solution Vehicle; Ophthalmic solution vehicle administered via topical ocular instillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Least Squares Mean Change From Baseline in Pre-CAE Anesthetized Schirmer Test Score at Day 28	The Schirmer test measures tear production. Following instillation of topical anesthetic drops, Schirmer strips were placed on the lower eye lids, eyes were closed, and strips remained in place for 5 minutes or until both strips reached a maximum score. The strips were removed, and the amount of wetting was recorded on a scale from 0 mm (no tear production) to 35 mm (maximum tear production). The test was performed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. The Day 28 value was subtracted from the Baseline value. A more positive change value indicates a better outcome. One eye (study eye) contributed data to the analysis. This is a co-primary endpoint.	Baseline (Day 1) (pre-treatment), Day 28
Least Squares Mean Change From Baseline in Pre-CAE (Controlled Adverse Environment) Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 28	Ocular discomfort was assessed using a Visual Analogue Scale (VAS) that ranged from 0 millimeters (mm) (no ocular discomfort) to 100 mm (maximum ocular discomfort). Ocular discomfort was assessed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. The Day 28 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes. This is a co-primary endpoint.	Baseline (Day 1) (pre-treatment), Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Least Squares Mean Change From Baseline in Pre-CAE Anesthetized Schirmer Test Score at Day 84	The Schirmer test measures tear production. Following instillation of topical anesthetic drops, Schirmer strips were the placed on the lower eye lids, eyes were closed, and strips remained in place for 5 minutes or until both strips reached a maximum score. The strips were removed, and the amount of wetting was recorded on a scale from 0 mm (no tear production) to 35 mm (maximum tear production). The test was performed at Baseline prior to CAE exposure and at Day 84 prior to CAE exposure. The Day 84 value was subtracted from the Baseline value. A more positive change value indicates a better outcome. One eye (study eye) contributed data to the analysis.	Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Pre-CAE Anesthetized Schirmer Test Score at Day 84	The Schirmer test measures tear production. Following instillation of topical anesthetic drops, Schirmer strips were the placed on the lower eye lids, eyes were closed, and strips remained in place for 5 minutes or until both strips reached a maximum score. The strips were removed, and the amount of wetting was recorded on a scale from 0 mm (no tear production) to 35 mm (maximum tear production). A higher score indicates a better outcome. The test was performed prior to CAE exposure. One eye (study eye) contributed data to the analysis.	Day 84
Least Squares Mean Pre-CAE Anesthetized Schirmer Test Score at Day 28	The Schirmer test measures tear production. Following instillation of topical anesthetic drops, Schirmer strips were the placed on the lower eye lids, eyes were closed, and strips remained in place for 5 minutes or until both strips reached a maximum score. The strips were removed, and the amount of wetting was recorded on a scale from 0 mm (no tear production) to 35 mm (maximum tear production). A higher score indicates a better outcome. The test was performed prior to CAE exposure. One eye (study eye) contributed data to the analysis.	Day 28
Mean Change From Baseline in Pre-CAE Ora Calibra® Ocular Discomfort Score (ODS) at Day 28	Ocular discomfort was assessed using a 5-point proprietary scale where 0=no discomfort and 4=constant discomfort. Ocular discomfort was assessed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. The Day 28 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. One eye (study eye) contributed data to the analysis.	Baseline (Day 1) (pre-treatment), Day 28
Mean Change From Baseline in Pre-CAE Ora Calibra® Ocular Discomfort Score (ODS) at Day 84	Ocular discomfort was assessed using a 5-point proprietary scale where 0=no discomfort and 4=constant discomfort. Ocular discomfort was assessed at Baseline prior to CAE exposure and at Day 84 prior to CAE exposure. The Day 84 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. One eye (study eye) contributed data to the analysis.	Baseline (Day 1) (pre-treatment), Day 84
Percentage of Subjects With a Baseline Anesthetized Schirmer Score Equal to or Less That 5 mm That Achieved an Anesthetized Schirmer Score of Equal to or Greater Than 10 mm at Day 84	The Schirmer test measures tear production. Following instillation of topical anesthetic drops, Schirmer strips were the placed on the lower eye lids, eyes were closed, and strips remained in place for 5 minutes or until both strips reached a maximum score. The strips were removed, and the amount of wetting was recorded on a scale from 0 mm (no tear production) to 35 mm (maximum tear production). The test was performed at Baseline prior to CAE exposure and at Day 84 prior to CAE exposure. A higher percentage indicates a better outcome. One eye (study eye) contributed data to the analysis.	Baseline (Day 1) (pre-treatment), Day 84
Percentage of Subjects With a Baseline Anesthetized Schirmer Score Equal to or Less That 5 mm That Achieved an Anesthetized Schirmer Score of Equal to or Greater Than 10 mm at Day 28	The Schirmer test measures tear production. Following instillation of topical anesthetic drops, Schirmer strips were the placed on the lower eye lids, eyes were closed, and strips remained in place for 5 minutes or until both strips reached a maximum score. The strips were removed, and the amount of wetting was recorded on a scale from 0 mm (no tear production) to 35 mm (maximum tear production). The test was performed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. A higher percentage indicates a better outcome. One eye (study eye) contributed data to the analysis.	Baseline (Day 1) (pre-treatment), Day 28
Percentage of Subjects That Achieved at Least a 10 mm Increase in Pre-CAE Anesthetized Schirmer Score Relative to Baseline at Day 28	The Schirmer test measures tear production. Following instillation of topical anesthetic drops, Schirmer strips were the placed on the lower eye lids, eyes were closed, and strips remained in place for 5 minutes or until both strips reached a maximum score. The strips were removed, and the amount of wetting was recorded on a scale from 0 mm (no tear production) to 35 mm (maximum tear production). The test was performed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. A higher percentage indicates a better outcome. One eye (study eye) contributed data to the analysis.	Baseline (Day 1) (pre-treatment), Day 28
Percentage of Subjects That Achieved at Least a 10 mm Increase in Pre-CAE Anesthetized Schirmer Score Relative to Baseline at Day 84	The Schirmer test measures tear production. Following instillation of topical anesthetic drops, Schirmer strips were the placed on the lower eye lids, eyes were closed, and strips remained in place for 5 minutes or until both strips reached a maximum score. The strips were removed, and the amount of wetting was recorded on a scale from 0 mm (no tear production) to 35 mm (maximum tear production). The test was performed at Baseline prior to CAE exposure and at Day 84 prior to CAE exposure. A higher percentage indicates a better outcome. One eye (study eye) contributed data to the analysis.	Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 28	Ocular discomfort was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular discomfort) to 100 mm (maximum ocular discomfort) prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.	Day 28
Least Squares Mean Change From Baseline in Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 84	Ocular discomfort was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular discomfort) to 100 mm (maximum ocular discomfort). Ocular discomfort was assessed at Baseline prior to CAE exposure and at Day 84 prior to CAE exposure. The Day 84 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.	Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 84	Ocular discomfort was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular discomfort) to 100 mm (maximum ocular discomfort) prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.	Day 84
Least Squares Mean Change From Baseline in Pre-CAE Pain Score on a Visual Analogue Scale at Day 84	Ocular pain was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain). Ocular pain was assessed at Baseline prior to CAE exposure and at Day 84 prior to CAE exposure. The Day 84 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.	Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Pre-CAE Pain Score on a Visual Analogue Scale at Day 84	Ocular pain was assessed prior to CAE exposure using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain) prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.	Day 84
Least Squares Mean Change From Baseline in Pre-CAE Pain Score on a Visual Analogue Scale at Day 28	Ocular pain was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain). Ocular pain was assessed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. The Day 28 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.	Baseline (Day 1) (pre-treatment), Day 28
Least Squares Mean Pre-CAE Pain Score on a Visual Analogue Scale at Day 28	Ocular pain was assessed prior to CAE exposure using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain) prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.	Day 28
Least Squares Mean Change From Baseline in Post-CAE Pain Score on a Visual Analogue Scale at Day 84	Ocular pain was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain). Ocular pain was assessed at Baseline prior to CAE exposure and at Day 84 following CAE exposure. The Day 84 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.	Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Post-CAE Pain Score on a Visual Analogue Scale at Day 84	Ocular pain was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain) following CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.	Day 84
Least Squares Mean Change From Baseline in Post-CAE Pain Score on a Visual Analogue Scale at Day 28	Ocular pain was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain). Ocular pain was assessed at Baseline prior to CAE exposure and at Day 28 following CAE exposure. The Day 28 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.	Baseline (Day 1) (pre-treatment), Day 28
Least Squares Mean Post-CAE Pain Score on a Visual Analogue Scale at Day 28	Ocular pain was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain) following CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.	Day 28
Least Squares Mean Change From Baseline in Pre-CAE Global SANDE Questionnaire Score at Day 28	The SANDE questionnaire assesses the frequency and severity of dry eye disease symptoms. Subjects used 2 unique, 100 mm Visual Analogue Scales (VAS) to mark the frequency of symptoms (0=rarely, 100=all the time) and the severity of symptoms (0=very mild, 100=very severe) for both eyes together. The Global SANDE score was calculated by multiplying the frequency score by the severity score and obtaining the square root. The final value was rounded nearest whole number. The SANDE questionnaire was completed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. The Day 28 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.	Baseline (Day 1) (pre-treatment), Day 28
Least Squares Mean Pre-CAE Global SANDE Questionnaire Score at Day 28	The SANDE questionnaire assesses the frequency and severity of dry eye disease symptoms. Subjects used 2 unique, 100 mm Visual Analogue Scales (VAS) to mark the frequency of symptoms (0=rarely, 100=all the time) and the severity of symptoms (0=very mild, 100=very severe) for both eyes together. The Global SANDE score was calculated by multiplying the frequency score by the severity score and obtaining the square root. The final value was rounded nearest whole number. The SANDE questionnaire was completed prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.	Day 28
Least Squares Mean Change From Baseline in Pre-CAE Global SANDE Questionnaire Score at Day 84	The SANDE questionnaire assesses the frequency and severity of dry eye disease symptoms. Subjects used 2 unique, 100 mm Visual Analogue Scales (VAS) to mark the frequency of symptoms (0=rarely, 100=all the time) and the severity of symptoms (0=very mild, 100=very severe) for both eyes together. The Global SANDE score was calculated by multiplying the frequency score by the severity score and obtaining the square root. The final value was rounded nearest whole number. The SANDE questionnaire was completed at Baseline prior to CAE exposure and at Day 84 prior to CAE exposure. The Day 84 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.	Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Pre-CAE Global SANDE Questionnaire Score at Day 84	The SANDE questionnaire assesses the frequency and severity of dry eye disease symptoms. Subjects used 2 unique, 100 mm Visual Analogue Scales (VAS) to mark the frequency of symptoms (0=rarely, 100=all the time) and the severity of symptoms (0=very mild, 100=very severe) for both eyes together. The Global SANDE score was calculated by multiplying the frequency score by the severity score and obtaining the square root. The final value was rounded nearest whole number. The SANDE questionnaire was completed prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.	Day 84
Least Squares Mean Change From Baseline in Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 28	Eye dryness was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no eye dryness) to 100 mm (maximum eye dryness). Eye dryness was assessed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. The Day 28 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.	Baseline (Day 1) (pre-treatment), Day 28
Least Squares Mean Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 28	Eye dryness was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no eye dryness) to 100 mm (maximum eye dryness) prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.	Day 28
Least Squares Mean Change From Baseline in Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 84	Eye dryness was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no eye dryness) to 100 mm (maximum eye dryness). Eye dryness was assessed at Baseline prior to CAE exposure and at Day 84 prior to CAE exposure. The Day 84 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.	Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 84	Eye dryness was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no eye dryness) to 100 mm (maximum eye dryness) prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.	Day 84
Least Squares Mean Change From Baseline in Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 14	Ocular discomfort was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular discomfort) to 100 mm (maximum ocular discomfort). Ocular discomfort was assessed at Baseline prior to CAE exposure and at Day 14 prior to CAE exposure. The Day 14 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.	Baseline (Day 1) (pre-treatment), Day 14
Least Squares Mean Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 14	Ocular discomfort was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular discomfort) to 100 mm (maximum ocular discomfort) prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.	Day 14
Least Squares Mean Change From Baseline in Pre-CAE Pain Score on a Visual Analogue Scale at Day 14	Ocular pain was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain). Ocular pain was assessed at Baseline prior to CAE exposure and at Day 14 prior to CAE exposure. The Day 14 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.	Baseline (Day 1) (pre-treatment), Day 14
Least Squares Mean Pre-CAE Pain Score on a Visual Analogue Scale at Day 14	Ocular pain was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain) prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.	Day 14
Least Squares Mean Change From Baseline in Pre-CAE Global SANDE Questionnaire Score at Day 14	The SANDE questionnaire assesses the frequency and severity of dry eye disease symptoms. Subjects used 2 unique, 100 mm Visual Analogue Scales (VAS) to mark the frequency of symptoms (0=rarely, 100=all the time) and the severity of symptoms (0=very mild, 100=very severe) for both eyes together. The Global SANDE score was calculated by multiplying the frequency score by the severity score and obtaining the square root. The final value was rounded nearest whole number. The SANDE questionnaire was completed at Baseline prior to CAE exposure and at Day 14 prior to CAE exposure. The Day 14 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.	Baseline (Day 1) (pre-treatment), Day 14
Least Squares Mean Pre-CAE Global SANDE Questionnaire Score at Day 14	The SANDE questionnaire assesses the frequency and severity of dry eye disease symptoms. Subjects used 2 unique, 100 mm Visual Analogue Scales (VAS) to mark the frequency of symptoms (0=rarely, 100=all the time) and the severity of symptoms (0=very mild, 100=very severe) for both eyes together. The Global SANDE score was calculated by multiplying the frequency score by the severity score and obtaining the square root. The final value was rounded nearest whole number. The SANDE questionnaire was completed prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.	Day 14
Least Squares Mean Change From Baseline in Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 14	Eye dryness was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no eye dryness) to 100 mm (maximum eye dryness). Eye dryness was assessed at Baseline prior to CAE exposure and at Day 14 prior to CAE exposure. The Day 14 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.	Baseline (Day 1) (pre-treatment), Day 14
Least Squares Mean Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 14	Eye dryness was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no eye dryness) to 100 mm (maximum eye dryness) prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.	Day 14

Collaborators and Investigators

• Sponsor: Aerie Pharmaceuticals
• Investigators: Study Director: Scientific Advisor, Clinical Research and Development, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Actual): July 17, 2021
• Study Completion (Actual): July 17, 2021

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: AR-15512-CS201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No