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

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04084483
• Other study ID #: K-161-2.01US
• Status: Completed
• Phase: Phase 2
• Start date: August 4, 2019
• Est. completion date: January 9, 2020

Study information

• Verified date: February 2023
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: January 9, 2020
• Est. primary completion date: January 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• K-161
K-161 alternate dosage

Other:
• Placebo (Vehicle)
Placebo solution

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts
United States	Central Maine Eye Care	Lewiston	Maine
United States	Total Eye Care, P.A.	Memphis	Tennessee
United States	Eye Research Foundation	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Change in Tear Film Break-up Time (TFBUT) Post-CAE		Baseline to Day 29
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Tear Film Break-Up Time (Pre CAE)		Baseline to Day 29
Secondary	Change in Tear Osmolarity (Pre CAE)		Baseline to Day 29
Secondary	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
Secondary	Change in Blink Rate (Pre CAE)	Blinks per 60 seconds.	Baseline to Day 29
Secondary	Change in Ocular Discomfort Scale (Pre CAE)	Ora Calibra® Ocular Discomfort Scale ranging from 0 to 4	Baseline to Day 29
Secondary	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
Secondary	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
Secondary	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