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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Schirmer test with no anesthetic | Experimental | Both eyes will be treated. |
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| Treatment with Schirmer test with anesthetic | Experimental | Both eyes will be treated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.003% AR-15512 to be administered in both eyes | Drug | Two rounds of Schirmer tests, performed without anesthetic (per randomization), before and after instillation of 0.003% AR-15512 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle S Senchyna, PhD | Aerie Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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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.
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| Vehicle to be administered in both eyes | Drug | Two rounds of Schirmer tests, performed without anesthetic, before and after instillation of Vehicle |
|
| 0.003% AR-15512 to be administered in both eyes | Drug | Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of 0.003% AR-15512 |
|
| Vehicle to be administered in both eyes | Drug | Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of Vehicle |
|
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 |