Study Evaluating Techniques for Measuring Tear Production

Aerie Pharmaceuticals40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Dry Eye Disease

Interventions

0.003% AR-15512 to be administered in both eyesDRUG

Two rounds of Schirmer tests, performed without anesthetic (per randomization), before and after instillation of 0.003% AR-15512

Vehicle to be administered in both eyesDRUG

Two rounds of Schirmer tests, performed without anesthetic, before and after instillation of Vehicle

0.003% AR-15512 to be administered in both eyesDRUG

Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of 0.003% AR-15512

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Eye Research Foundation

Newport Beach, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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