Study Evaluating Techniques for Measuring Tear Production

Phase 1

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: 0.003% AR-15512 to be administered in both eyes; Drug: Vehicle to be administered in both eyes

• Registration Number: NCT05497479
• Lead Sponsor: Aerie Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-09
• Primary Completion: 2021-12-10
• Study Completion: 2021-12-10
• Study First Submitted: 2022-07-26
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-09
• Last Update Submitted: 2022-08-09
• Study First Posted: 2022-08-11
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with Schirmer test with anesthetic	0.003% AR-15512 to be administered in both eyes	Both eyes will be treated.
Treatment with Schirmer test with no anesthetic	0.003% AR-15512 to be administered in both eyes	Both eyes will be treated.
Treatment with Schirmer test with anesthetic	Vehicle to be administered in both eyes	Both eyes will be treated.
Treatment with Schirmer test with no anesthetic	Vehicle to be administered in both eyes	Both eyes will be treated.

Primary Outcome Measures

Name	Time	Method
Unanesthetized Schirmer test	Day 1	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.
Anesthetized Schirmer test	Day 1	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.

Trial Locations

Locations (1)

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States