The purpose of this study is to evaluate the effect of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) on ocular surface characteristics of subjects with dry eye disease (DED).
Qualified subjects will enter a 14-day run-in period, followed by a 13-week randomized treatment period, for a total individual duration of participation of approximately 15 weeks. During the run-in period, subjects will administer Artificial Tears (REFRESH® Classic) as one drop in each eye twice daily. This is a Phase 3b study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
79
Ophthalmic solution administered via topical ocular instillation
Commercially available, preservative-free lubricant eye drops
Butchertown Clinical Trials
Louisville, Kentucky, United States
Oculus Research
Garner, North Carolina, United States
Wilmington Eye
Leland, North Carolina, United States
CORE, Inc.
Shelby, North Carolina, United States
Percentage change from baseline in goblet cell density at Day 90
Goblet cells are specialized epithelial cells that secrete mucins onto the ocular surface to help hydrate and lubricate the eye surface. Samples of conjunctiva will be collected on filter papers based on a technique called impression cytology. The filter papers will then be processed in a lab to identify the number of goblet cells. The percent change in goblet cell density at Day 90 compared to Day 1 (Baseline) will be calculated. A positive change value will indicate an improvement.
Time frame: Baseline (Day 1 pre-instillation), Day 90
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