This study will evaluate the efficacy, safety and tolerability of perfluorohexyloctane (NOV03) at two different dosing regimens compared to saline solution in subjects with Dry Eye Disease (DED).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
336
Investigational site
Artesia, California, United States
Investigational Site
Newport Beach, California, United States
Investigational Site
Newport Beach, California, United States
Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading)
The primary efficacy variable was comparison of absolute and change from baseline between treatments for total Corneal Fluorescein Staining (tCFS) according to the National Eye Institute grading (NEI Scale) at week 8 The NEI Scale is a standardized grading system. 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage.
Time frame: baseline and 2 months
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Investigational Site
Santa Ana, California, United States
Investigational Site
Torrance, California, United States
Investigational site
Jacksonville, Florida, United States
Investigational Site
Lake Villa, Illinois, United States
Investigational Site
Kansas City, Missouri, United States
Investigational Site
Pennington, New Jersey, United States
Investigational Site
Nashville, Tennessee, United States
...and 1 more locations