Study Evaluating Techniques for Measuring Tear Production

• Status: Completed
• Trial end date: 2021-12-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aerie Pharmaceuticals

Criteria

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.