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
80
Investigational ophthalmic solution administered via topical instillation
Commercially available, preservative-free lubricant eye drops administered via topical instillation
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
Least Squares Mean Percentage Change From Baseline in Goblet Cell Density at Day 90 for 0.003% AR-15512
Goblet cells are specialized epithelial cells that secrete mucins onto the ocular surface to help hydrate and lubricate the eye surface. Samples of conjunctiva were collected on filter papers based on a technique called impression cytology. The filter papers were then processed in a lab to measure the number of goblet cells (cells/mm2). The percent change in goblet cell density at Day 90 compared to Day 1 (Baseline) was calculated. A positive change value indicates an improvement. Only one eye (study eye) contributed data to the analysis. This outcome measure was pre-specified for 0.003% AR-15512 arm only.
Time frame: Day 1 pre-instillation (Baseline), Day 90 post instillation
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