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

Phase 2

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: K-161; Other: Placebo (Vehicle)

• Registration Number: NCT04084483
• Lead Sponsor: Kowa Research Institute, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-04
• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-10
• Primary Completion: 2020-01-09
• Study Completion: 2020-01-09
• Disposition First Submitted: 2021-01-04
• Results First Submitted: 2023-01-03
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-16
• Last Update Submitted: 2023-02-16
• Results First Posted: 2023-03-15
• Disposition First Posted: 2023-03-15
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	K-161	K-161 Ophthalmic Solution Dose A.
Group 2	K-161	K-161 Ophthalmic Solution Dose B.
Group 4	Placebo (Vehicle)	Vehicle Solution Dose.
Group 3	K-161	K-161 Ophthalmic Solution Dose C.

Primary Outcome Measures

Name	Time	Method
Change in Inferior Corneal Fluorescein Staining Score Post Controlled Adverse Environment (Post-Controlled Adverse Environment (CAE))	Baseline to Day 29	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.
Change in Ocular Discomfort Scale Post-CAE	Baseline to Day 29	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.

Secondary Outcome Measures

Name	Time	Method
Change in Tear Osmolarity (Pre CAE)	Baseline to Day 29
Change in Lissamine Green Staining (Pre-CAE) Using the Ora Calibra® Scale (Conjunctival Sum)	Baseline to Day 29	Ora Calibra Scale which is 0 to 4 scale with increasing half-units and where higher numbers indicating more severe staining.
Change in Tear Film Break-Up Time (Pre CAE)	Baseline to Day 29
Change in Unanesthetized Schirmer's Test (Pre CAE)	Baseline to Day 29	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.
Change in Ocular Discomfort Scale (Pre CAE)	Baseline to Day 29	Ora Calibra® Ocular Discomfort Scale ranging from 0 to 4
Change in Schirmer's Test Value (Unanesthetized) Pre-CAE	Baseline to Day 29	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.
Change in Conjunctival Redness (Pre-CAE)	Baseline to Day 29	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.
Change in Blink Rate (Pre CAE)	Baseline to Day 29	Blinks per 60 seconds.
Change in Tear Film Break-up Time (TFBUT) Post-CAE	Baseline to Day 29
Change in Fluorescein Staining Scores (Pre-CAE®)	Baseline to Day 29	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.
Change in Ocular Discomfort and 4-Symptom Questionnaire (Pre CAE)	Baseline to Day 29	Scores ranging from 0 to 5. A score of 0 indicates no discomfort/symptoms and a score of 5 indicates worst discomfort/symptoms.
Change in Visual Analog Scale (Pre CAE)	Baseline to Day 29	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".
Change in Ocular Surface Disease Index Score (Pre-CAE) - Total OSDI	Baseline to Day 29	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.

Trial Locations

Locations (4)

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States

Total Eye Care, P.A.; 🇺🇸 Memphis, Tennessee, United States

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States

Central Maine Eye Care; 🇺🇸 Lewiston, Maine, United States