A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease

The objective of the study is to assess the safety, efficacy, optimum dosage, and dosing regimen of K-161 in adult subjects with moderate to severe dry eye disease.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: K-161; Other: Placebo (Vehicle)

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
  • Maine
    • Lewiston, Maine, United States, 04240
      • Central Maine Eye Care
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, P.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be at least 18 years of age at the time of informed consent visit.
• Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptoms.
• Meet all 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.
• Must not meet any other exclusion criteria outlined in the clinical study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; K-161 Ophthalmic Solution Dose A.	Drug: K-161; K-161 alternate dosage
Experimental: Group 2; K-161 Ophthalmic Solution Dose B.	Drug: K-161; K-161 alternate dosage
Experimental: Group 3; K-161 Ophthalmic Solution Dose C.	Drug: K-161; K-161 alternate dosage
Placebo Comparator: Group 4; Vehicle Solution Dose.	Other: Placebo (Vehicle); Placebo solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Inferior Corneal Fluorescein Staining Score Post Controlled Adverse Environment (Post-Controlled Adverse Environment (CAE))	Fluorescein Staining is measured with the Ora Calibra® Corneal and Conjunctival Staining Scale which is a 0 to 4 scale with increasing half-units and where higher numbers indicating more severe staining. K-161 compared to Vehicle. When study patients are exposed to Controlled Adverse Environment (CAE) in terms of relative humidity, temperature, airflow, and visual tasking, the ocular surface is stressed to react. This controlled environmental stress creates a consistent response that's reproducible over time.	Baseline to Day 29
Change in Ocular Discomfort Scale Post-CAE	Ocular discomfort scores were subjectively graded by the subjects using the Ora Calibra® Ocular Discomfort Scale from 0 to 4 where 0 = No Discomfort and 4 = Constant Discomfort.	Baseline to Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Schirmer's Test Value (Unanesthetized) Pre-CAE	Measured with Schirmer's test strip with the length of the moistened area recorded in mm. Lower values indicate less tears produced in the eye.	Baseline to Day 29
Change in Tear Film Break-up Time (TFBUT) Post-CAE		Baseline to Day 29
Change in Fluorescein Staining Scores (Pre-CAE®)	Fluorescein Staining is measured with the Ora Calibra® Corneal and Conjunctival Staining Scale which is a 0 to 4 scale with increasing half-units and where higher numbers indicating more severe staining.	Baseline to Day 29
Change in Lissamine Green Staining (Pre-CAE) Using the Ora Calibra® Scale (Conjunctival Sum)	Ora Calibra Scale which is 0 to 4 scale with increasing half-units and where higher numbers indicating more severe staining.	Baseline to Day 29
Change in Conjunctival Redness (Pre-CAE)	Conjunctival Redness Scale ranges from 0 to 4, where 0 = normal, without vasodilation and 4 = Broad Ciliary and Prominent, Horizontal Conjunctival Vasodilation. Higher scores indicate worsening conjunctival redness.	Baseline to Day 29
Change in Tear Film Break-Up Time (Pre CAE)		Baseline to Day 29
Change in Tear Osmolarity (Pre CAE)		Baseline to Day 29
Change in Unanesthetized Schirmer's Test (Pre CAE)	Measured with Schirmer's test strip with the length of the moistened area recorded in mm. Lower values indicate less tears produced in the eye.	Baseline to Day 29
Change in Blink Rate (Pre CAE)	Blinks per 60 seconds.	Baseline to Day 29
Change in Ocular Discomfort Scale (Pre CAE)	Ora Calibra® Ocular Discomfort Scale ranging from 0 to 4	Baseline to Day 29
Change in Ocular Discomfort and 4-Symptom Questionnaire (Pre CAE)	Scores ranging from 0 to 5. A score of 0 indicates no discomfort/symptoms and a score of 5 indicates worst discomfort/symptoms.	Baseline to Day 29
Change in Visual Analog Scale (Pre CAE)	The length of the assessment line was 100 mm; a measure of 0 mm corresponded to "no discomfort" and 100 mm corresponds to "maximal discomfort".	Baseline to Day 29
Change in Ocular Surface Disease Index Score (Pre-CAE) - Total OSDI	The OSDI© is comprised of 12 questions, with each question assessed on a scale ranging from 0 to 4 where 0 = none of the time, 1 = some of the time, 2 = half of the time, 3 = most of the time, and 4 = all of the time. The range of total score is "0 to 100". "Subscale" scores are not reported. Higher score represents a worsen outcome. The total score is the sum of subscales.	Baseline to Day 29

Collaborators and Investigators

• Sponsor: Kowa Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2019
• Primary Completion (Actual): January 9, 2020
• Study Completion (Actual): January 9, 2020

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: K-161-2.01US

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No