Study Evaluating Techniques for Measuring Tear Production (MTP)

A Phase 1 Study Evaluating Techniques for Measuring Tear Production

This will be a vehicle-controlled, masked, randomized study conducted at a single site in the United States. All participants enrolled will have Dry Eye Disease (DED). The study will consist of 2 Visits. At Visit 1, eligibility will be assessed at Screening. All eligible subjects will then be enrolled and randomized to one of two treatment groups (1:1): active (0.003% AR-15512) or control (AR-15512 vehicle). Subjects in each treatment group will then be randomized 1:1 to which Visit (Visit 1 or 2) anesthetic will be used with the Schirmer test.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: 0.003% AR-15512 to be administered in both eyes; Drug: Vehicle to be administered in both eyes; Drug: 0.003% AR-15512 to be administered in both eyes; Drug: Vehicle to be administered in both eyes

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have used, and/or desired to use artificial tears for DED symptoms within 6 months prior to Visit 1
• Within the last year from Visit 1, have a documented Schirmer test with or without topical anesthesia score ≥ 2 and ≤ 10 mm/5 min
• Within the last year from Visit 1, have documented symptoms of DED
• Corrected Visual Acuity (Snellen) 20/200 or better in both

Exclusion Criteria:

• Use of artificial tears within 2 hours prior to Visit 1
• Use of ocular cyclosporine or other prescription ophthalmic solution for DED (e.g., Restasis®, Cequa®, Xiidra®) within 30 days of Visit 1 or anticipated use during the study period.
• Regular use of any topical ocular non-DED medication or use of a topical ocular non-DED medication within 2 hours of Visit 1
• Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study
• Punctal or intracanalicular plug present in either eyelid or anticipated plug insertion or occlusion at any time during the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with Schirmer test with no anesthetic; Both eyes will be treated.	Drug: 0.003% AR-15512 to be administered in both eyes; Two rounds of Schirmer tests, performed without anesthetic (per randomization), before and after instillation of 0.003% AR-15512; Drug: Vehicle to be administered in both eyes; Two rounds of Schirmer tests, performed without anesthetic, before and after instillation of Vehicle; Drug: 0.003% AR-15512 to be administered in both eyes; Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of 0.003% AR-15512; Drug: Vehicle to be administered in both eyes; Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of Vehicle
Experimental: Treatment with Schirmer test with anesthetic; Both eyes will be treated.	Drug: 0.003% AR-15512 to be administered in both eyes; Two rounds of Schirmer tests, performed without anesthetic (per randomization), before and after instillation of 0.003% AR-15512; Drug: Vehicle to be administered in both eyes; Two rounds of Schirmer tests, performed without anesthetic, before and after instillation of Vehicle; Drug: 0.003% AR-15512 to be administered in both eyes; Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of 0.003% AR-15512; Drug: Vehicle to be administered in both eyes; Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, measured in whole millimeters to a maximum score of 35 mm. An ≥ 10 mm score indicates a better outcome.	Day 1
Unanesthetized Schirmer test	Mean change in Unanesthetized Schirmer score Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean change indicates a better outcome.	Day 1
Unanesthetized Schirmer test	Mean Unanesthetized Schirmer score Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean value indicates a better outcome.	Day 1
Anesthetized Schirmer test	Proportion of subjects ≥ 10 mm increase in anesthetized Schirmer score Schirmer strips placed with anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. An ≥ 10 mm score indicates a better outcome.	Day 1
Anesthetized Schirmer test	Mean change in anesthetized Schirmer score. Schirmer strips placed without anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean change indicates a better outcome.	Day 1
Anesthetized Schirmer test	Mean anesthetized Schirmer score Schirmer strips placed with anesthesia, in both eyes measure the amount of tear wetting over 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean value indicates a better outcome.	Day 1

Collaborators and Investigators

• Sponsor: Aerie Pharmaceuticals
• Investigators: Study Director: Michelle S Senchyna, PhD, Aerie Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Actual): December 10, 2021
• Study Completion (Actual): December 10, 2021

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

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
• Other Study ID Numbers: 21-110-A

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
• product manufactured in and exported from the U.S.: No