The purpose of the study is to compare the efficacy and safety of 5% tavilermide ophthalmic solution to placebo for the treatment of the signs and symptoms of dry eye disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
642
Twice a day topicial dosing
Twice a day topical dosing
Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale
The National Eye Institute (NEI) scale is a standardized grading system of 0-3 was used for each of the 5 areas on each cornea (central, superior, temporal, nasal, and inferior). Grade 0 was specified when no staining is present. The maximum score was 15.
Time frame: Baseline to Day 85
Change From Baseline in Eye Dryness Score as Measured by the VAS
The Visual Analog Scale (VAS) where subjects were asked to rate their eye dryness (OU) by placing a vertical mark on the horizontal line to indicate their current level of discomfort. 0 mm corresponds to "No Discomfort," and 100 mm corresponds to "Maximal Discomfort." The length of the assessment line is 100 mm.
Time frame: Baseline to Day 85
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