This trial will evaluate the efficacy, safety, and tolerability of NOV03 ophthalmic solution in comparison to a saline control for the treatment of the signs and symptoms of Dry Eye Disease (DED) associated with Meibomian Gland Dysfunction (MGD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
599
Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at Day 57
Corneal Fluorescein Staining (tCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining, 3 corresponds to maximum staining. The total score is the sum of the 5 subregions ranging from 0-15.
Time frame: Assessed from Baseline to Day 57
Change From Baseline of Dryness Score at Day 57
Dryness Score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort).
Time frame: Assessed from Baseline to Day 57
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bausch Site 124
Birmingham, Alabama, United States
Bausch Site 125
Scottsdale, Arizona, United States
Bausch Site 110
Glendale, California, United States
Bausch Site 121
Long Beach, California, United States
Bausch Site 102
Mission Hills, California, United States
Bausch Site 101
Newport Beach, California, United States
Bausch Site 116
Rancho Cordova, California, United States
103
Torrance, California, United States
Bausch Site 123
Torrance, California, United States
Bausch Site 127
Danbury, Connecticut, United States
...and 19 more locations