Study Evaluating Techniques for Measuring Tear Production

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Study Evaluating Techniques for Measuring Tear Production

Conditions
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Dry Eye Disease

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All eligible subjects will be enrolled and randomized (1:1) to one of two treatment groups: active (0.003% AR-15512) or control (AR-15512 vehicle). Following enrollment, subjects in the two treatment groups will each be randomized 1:1 to which Visit (Visit 1 or 2) anesthetic will be used with the Schirmer test.
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |