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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: K-161
* Other: Placebo (Vehicle)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |