A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease
Overview
- Phase
- Phase 2
- Intervention
- K-161
- Conditions
- Dry Eye Disease
- Sponsor
- Kowa Research Institute, Inc.
- Enrollment
- 238
- Locations
- 4
- Primary Endpoint
- Change in Inferior Corneal Fluorescein Staining Score Post Controlled Adverse Environment (Post-Controlled Adverse Environment (CAE))
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Group 1
K-161 Ophthalmic Solution Dose A.
Intervention: K-161
Group 2
K-161 Ophthalmic Solution Dose B.
Intervention: K-161
Group 3
K-161 Ophthalmic Solution Dose C.
Intervention: K-161
Group 4
Vehicle Solution Dose.
Intervention: Placebo (Vehicle)
Outcomes
Primary Outcomes
Change in Inferior Corneal Fluorescein Staining Score Post Controlled Adverse Environment (Post-Controlled Adverse Environment (CAE))
Time Frame: Baseline to Day 29
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
Time Frame: Baseline to Day 29
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 Outcomes
- Change in Lissamine Green Staining (Pre-CAE) Using the Ora Calibra® Scale (Conjunctival Sum)(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)(Baseline to Day 29)
- Change in Ocular Discomfort Scale (Pre CAE)(Baseline to Day 29)
- Change in Schirmer's Test Value (Unanesthetized) Pre-CAE(Baseline to Day 29)
- Change in Conjunctival Redness (Pre-CAE)(Baseline to Day 29)
- Change in Blink Rate (Pre CAE)(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®)(Baseline to Day 29)
- Change in Ocular Discomfort and 4-Symptom Questionnaire (Pre CAE)(Baseline to Day 29)
- Change in Visual Analog Scale (Pre CAE)(Baseline to Day 29)
- Change in Ocular Surface Disease Index Score (Pre-CAE) - Total OSDI(Baseline to Day 29)