search
Back to results

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

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
K-161
Placebo (Vehicle)
Sponsored by
Kowa Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eye Research Foundation
  • Central Maine Eye Care
  • Andover Eye Associates
  • Total Eye Care, P.A.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

K-161 Ophthalmic Solution Dose A.

K-161 Ophthalmic Solution Dose B.

K-161 Ophthalmic Solution Dose C.

Vehicle Solution Dose.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Change in Tear Film Break-up Time (TFBUT) Post-CAE
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.
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.
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.
Change in Tear Film Break-Up Time (Pre CAE)
Change in Tear Osmolarity (Pre CAE)
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.
Change in Blink Rate (Pre CAE)
Blinks per 60 seconds.
Change in Ocular Discomfort Scale (Pre CAE)
Ora Calibra® Ocular Discomfort Scale ranging from 0 to 4
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.
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".
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.

Full Information

First Posted
August 13, 2019
Last Updated
February 16, 2023
Sponsor
Kowa Research Institute, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04084483
Brief Title
A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease
Official Title
A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 4, 2019 (Actual)
Primary Completion Date
January 9, 2020 (Actual)
Study Completion Date
January 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Research Institute, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
K-161 Ophthalmic Solution Dose A.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
K-161 Ophthalmic Solution Dose B.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
K-161 Ophthalmic Solution Dose C.
Arm Title
Group 4
Arm Type
Placebo Comparator
Arm Description
Vehicle Solution Dose.
Intervention Type
Drug
Intervention Name(s)
K-161
Intervention Description
K-161 alternate dosage
Intervention Type
Other
Intervention Name(s)
Placebo (Vehicle)
Intervention Description
Placebo solution
Primary Outcome Measure Information:
Title
Change in Inferior Corneal Fluorescein Staining Score Post Controlled Adverse Environment (Post-Controlled Adverse Environment (CAE))
Description
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.
Time Frame
Baseline to Day 29
Title
Change in Ocular Discomfort Scale Post-CAE
Description
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.
Time Frame
Baseline to Day 29
Secondary Outcome Measure Information:
Title
Change in Schirmer's Test Value (Unanesthetized) Pre-CAE
Description
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.
Time Frame
Baseline to Day 29
Title
Change in Tear Film Break-up Time (TFBUT) Post-CAE
Time Frame
Baseline to Day 29
Title
Change in Fluorescein Staining Scores (Pre-CAE®)
Description
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.
Time Frame
Baseline to Day 29
Title
Change in Lissamine Green Staining (Pre-CAE) Using the Ora Calibra® Scale (Conjunctival Sum)
Description
Ora Calibra Scale which is 0 to 4 scale with increasing half-units and where higher numbers indicating more severe staining.
Time Frame
Baseline to Day 29
Title
Change in Conjunctival Redness (Pre-CAE)
Description
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.
Time Frame
Baseline to Day 29
Title
Change in Tear Film Break-Up Time (Pre CAE)
Time Frame
Baseline to Day 29
Title
Change in Tear Osmolarity (Pre CAE)
Time Frame
Baseline to Day 29
Title
Change in Unanesthetized Schirmer's Test (Pre CAE)
Description
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.
Time Frame
Baseline to Day 29
Title
Change in Blink Rate (Pre CAE)
Description
Blinks per 60 seconds.
Time Frame
Baseline to Day 29
Title
Change in Ocular Discomfort Scale (Pre CAE)
Description
Ora Calibra® Ocular Discomfort Scale ranging from 0 to 4
Time Frame
Baseline to Day 29
Title
Change in Ocular Discomfort and 4-Symptom Questionnaire (Pre CAE)
Description
Scores ranging from 0 to 5. A score of 0 indicates no discomfort/symptoms and a score of 5 indicates worst discomfort/symptoms.
Time Frame
Baseline to Day 29
Title
Change in Visual Analog Scale (Pre CAE)
Description
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".
Time Frame
Baseline to Day 29
Title
Change in Ocular Surface Disease Index Score (Pre-CAE) - Total OSDI
Description
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.
Time Frame
Baseline to Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Central Maine Eye Care
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Total Eye Care, P.A.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs