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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
238
K-161 alternate dosage
Placebo solution
Eye Research Foundation
Newport Beach, California, United States
Central Maine Eye Care
Lewiston, Maine, United States
Andover Eye Associates
Andover, Massachusetts, United States
Total Eye Care, P.A.
Memphis, Tennessee, United States
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.
Time frame: 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.
Time frame: Baseline to Day 29
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.
Time frame: Baseline to Day 29
Change in Tear Film Break-up Time (TFBUT) Post-CAE
Time frame: 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.
Time frame: Baseline to Day 29
Change in Lissamine Green Staining (Pre-CAE) Using the Ora Calibra® Scale (Conjunctival Sum)
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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
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.
Time frame: Baseline to Day 29
Change in Tear Film Break-Up Time (Pre CAE)
Time frame: Baseline to Day 29
Change in Tear Osmolarity (Pre CAE)
Time frame: 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.
Time frame: Baseline to Day 29
Change in Blink Rate (Pre CAE)
Blinks per 60 seconds.
Time frame: Baseline to Day 29
Change in Ocular Discomfort Scale (Pre CAE)
Ora Calibra® Ocular Discomfort Scale ranging from 0 to 4
Time frame: 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.
Time frame: 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".
Time frame: 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.
Time frame: Baseline to Day 29