The purpose of this study is to assess the efficacy and safety of K-161 ophthalmic solution for the treatment of moderate to severe dry eye disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
644
Change in EDS (VAS) From Baseline to Day 85
* Eye Dryness Score (EDS) on Visual analog scale (VAS) * Participant self rated level of severity where, 0 mm corresponds to "None" and 100 mm corresponds to "Worst Possible".
Time frame: Baseline to Day 85
Change in Conjunctival Sum Fluorescein Staining Score From Baseline to Day 85 (Study Eye)
* Assessed by expanded National Eye Institute (NEI) scale * Conjunctival sum will be assessed as the sum of points in 6 conjunctival zones, and each zone will be graded on a 5-point scale from 0 - no conjunctival staining to 4 - severe staining of the area (0.5 increments would be allowed) * Minimum is 0 and maximum is 24 for Conjunctival Sum Fluorescein Staining Score.
Time frame: Baseline to Day 85
Change From Baseline to Day 85 in Total Eye Sum Fluorescein Staining Score (Study Eye)
* Assessed by expanded National Eye Institute (NEI) scale. * Total eye sum will be assessed as the sum of Corneal sum fluorescein staining score and conjunctival sum fluorescein staining score. * Minimum is 0 and maximum is 44 for Total Eye Sum Fluorescein Staining Score.
Time frame: Baseline to Day 85
Change From Baseline to Day 85 in Corneal Sum Fluorescein Staining Score (Study Eye)
* Assessed by expanded National Eye Institute (NEI) scale. * Corneal sum will be assessed as the sum of points in 5 corneal zones, and each zone will be graded on a 5-point scale from 0 - no punctate stain in the area to 4 - Severe diffuse (coalescent) macropunctate stain of the area (0.5 increments would be allowed) * Minimum is 0 and maximum is 20 for Corneal Sum Fluorescein Staining Score
Time frame: Baseline to Day 85
Change From Baseline to Day 85 in Ocular Surface Disease Index Score (OSDI©)
OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.
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The University of Alabama at Birmingham School of Optometry, Clinical Eye Research Center
Birmingham, Alabama, United States
Trinity Research Group
Dothan, Alabama, United States
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, United States
Citrus Valley Eyecare / Premiere Practice Management, LLC
Covina, California, United States
Orange County Ophthalmology Medical Group
Garden Grove, California, United States
Global Research Management
Glendale, California, United States
Inland Eye Specialists
Hemet, California, United States
United Medical Research Institute
Inglewood, California, United States
Premiere Practice Management, LLC
Los Angeles, California, United States
North Valley Eye Medical Group, Inc
Mission Hills, California, United States
...and 41 more locations
Time frame: Baseline to Day 85
Change From Baseline to Day 85 in Schirmer's Test (Unanesthetized) (Study Eye)
Length (mm) of the moistened area assessed by inserting a Schirmer test strip into the eye for 5 minutes to measure the production of tears.
Time frame: Baseline to Day 85
Change From Baseline to Day 85 in Tear Film Break-up Time (TFBUT) (Study Eye)
The time (in seconds) taken for the first dry spot to appear on the cornea after a complete blink (with the aid of a slit-lamp).
Time frame: Baseline to Day 85