A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease

Phase 3

Completed

Conditions: Dry Eye Disease

Interventions: Drug: K-161
Drug: Placebo

Registration Number: NCT05403827

Lead Sponsor: Kowa Research Institute, Inc.

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 644

Inclusion Criteria

Be at least 18 years of age at the time of Informed Consent
Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptom
Meet all other inclusion criteria outlined in the clinical study protocol

Exclusion Criteria

Have any clinically significant ocular condition
Have a history of corneal refractive surgery and/or any other ocular surgical procedure within 12 months
Meet any other exclusion criteria outlined in the clinical study protocol

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
K-161	K-161	K-161 Ophthalmic Solution
Placebo	Placebo	Vehicle Solution

Primary Outcome Measures

Name	Time	Method
Change in EDS (VAS) From Baseline to Day 85	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".
Change in Conjunctival Sum Fluorescein Staining Score From Baseline to Day 85 (Study Eye)	Baseline to Day 85	* 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Day 85 in Total Eye Sum Fluorescein Staining Score (Study Eye)	Baseline to Day 85	* 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.
Change From Baseline to Day 85 in Corneal Sum Fluorescein Staining Score (Study Eye)	Baseline to Day 85	* 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
Change From Baseline to Day 85 in Ocular Surface Disease Index Score (OSDI©)	Baseline to Day 85	OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.
Change From Baseline to Day 85 in Schirmer's Test (Unanesthetized) (Study Eye)	Baseline to Day 85	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.
Change From Baseline to Day 85 in Tear Film Break-up Time (TFBUT) (Study Eye)	Baseline to Day 85	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).

Trial Locations

Locations (50): 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
🇺🇸
Torrance, California, United States
North Valley Eye Medical Group, Inc
🇺🇸
Mission Hills, California, United States
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The University of Alabama at Birmingham School of Optometry, Clinical Eye Research Center
🇺🇸Birmingham, Alabama, United States