Clinical trial NCT04084483: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Disease
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-10
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Inferior Corneal Fluorescein Staining Score Post Controlled Adverse Environment (Post-Controlled Adverse Environment (CAE))
timeFrame: Baseline to Day 29
measure: Change in Ocular Discomfort Scale Post-CAE
timeFrame: Baseline to Day 29
Secondary outcomes:
measure: Change in Schirmer's Test Value (Unanesthetized) Pre-CAE
timeFrame: Baseline to Day 29
measure: Change in Tear Film Break-up Time (TFBUT) Post-CAE
timeFrame: Baseline to Day 29
measure: Change in Fluorescein Staining Scores (Pre-CAE®)
timeFrame: Baseline to Day 29
measure: Change in Lissamine Green Staining (Pre-CAE) Using the Ora Calibra® Scale (Conjunctival Sum)
timeFrame: Baseline to Day 29
measure: Change in Conjunctival Redness (Pre-CAE)
timeFrame: Baseline to Day 29
measure: Change in Tear Film Break-Up Time (Pre CAE)
timeFrame: Baseline to Day 29
measure: Change in Tear Osmolarity (Pre CAE)
timeFrame: Baseline to Day 29
measure: Change in Unanesthetized Schirmer's Test (Pre CAE)
timeFrame: Baseline to Day 29
measure: Change in Blink Rate (Pre CAE)
timeFrame: Baseline to Day 29
measure: Change in Ocular Discomfort Scale (Pre CAE)
timeFrame: Baseline to Day 29
measure: Change in Ocular Discomfort and 4-Symptom Questionnaire (Pre CAE)
timeFrame: Baseline to Day 29
measure: Change in Visual Analog Scale (Pre CAE)
timeFrame: Baseline to Day 29
measure: Change in Ocular Surface Disease Index Score (Pre-CAE) - Total OSDI
timeFrame: Baseline to Day 29
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Lewiston
country: United States
facility: Central Maine Eye Care
state: Maine
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Memphis
country: United States
facility: Total Eye Care, P.A.
state: Tennessee
Study officials:
References: