Dry Eye Disease
Conditions
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.
Interventions
DRUG0.003% AR-15512 to be administered in both eyes
Two rounds of Schirmer tests, performed without anesthetic (per randomization), before and after instillation of 0.003% AR-15512
DRUGVehicle to be administered in both eyes
Two rounds of Schirmer tests, performed without anesthetic, before and after instillation of Vehicle
Sponsors
Aerie Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unanesthetized Schirmer test | Day 1 | 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. |
| Anesthetized Schirmer test | Day 1 | 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. |
Countries
United States
Outcome results
None listed