Phase 2
N=238
A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease
Dry Eye Disease
Bottom Line
View on ClinicalTrials.gov: NCT04084483 ↗Enrolled (actual)
238
Serious AEs
1.3%
Results posted
Mar 2023
Primary outcome: Primary: Change in Inferior Corneal Fluorescein Staining Score Post Controlled Adverse Environment (Post-Controlled Adverse Environment (CAE)) — -0.57; -0.44 scores on a scale — p=0.2175
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- K-161 (Drug); Placebo (Vehicle) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kowa Research Institute, Inc.
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Inferior Corneal Fluorescein Staining Score Post Controlled Adverse Environment (Post-Controlled Adverse Environment (CAE)) |
-0.57; -0.44 | 0.2175 |
| PRIMARY Change in Ocular Discomfort Scale Post-CAE |
0.0; 0.0 | 0.3852 |
| SECONDARY Change in Schirmer's Test Value (Unanesthetized) Pre-CAE |
3.4; 2.2 | 0.2980 |
| SECONDARY Change in Tear Film Break-up Time (TFBUT) Post-CAE |
0.402; 0.132 | 0.0634 |
| SECONDARY Change in Fluorescein Staining Scores (Pre-CAE®) |
-0.28; -0.36; -0.50; -0.03; -0.22; -0.28 | 0.7388 |
| SECONDARY Change in Lissamine Green Staining (Pre-CAE) Using the Ora Calibra® Scale (Conjunctival Sum) |
-0.16; -0.25; -0.39 | 0.5990 |
| SECONDARY Change in Conjunctival Redness (Pre-CAE) |
-0.21; -0.20; -0.22 | 0.9146 |
| SECONDARY Change in Tear Film Break-Up Time (Pre CAE) |
0.312; 0.398; 0.242 | 0.4747 |
| SECONDARY Change in Tear Osmolarity (Pre CAE) |
-0.5; 1.0; 0.4 | 0.5985 |
| SECONDARY Change in Unanesthetized Schirmer's Test (Pre CAE) |
3.3; 3.1; 2.1 | 0.8330 |
| SECONDARY Change in Blink Rate (Pre CAE) |
0.1; 0.1; -0.2 | 0.9829 |
| SECONDARY Change in Ocular Discomfort Scale (Pre CAE) |
-0.3; -0.2; -0.5 | 0.5836 |
| SECONDARY Change in Ocular Discomfort and 4-Symptom Questionnaire (Pre CAE) |
-0.2; -0.2; -0.4; 0.1; 0.0; -0.1 | 0.7367 |
| SECONDARY Change in Visual Analog Scale (Pre CAE) |
-1.9; -7.6; -5.6; -3.1; -9.7; -6.1 | 0.1380 |
| SECONDARY Change in Ocular Surface Disease Index Score (Pre-CAE) - Total OSDI |
-3.2; -2.9; -7.8 | 0.9274 |
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.
Data sourced from ClinicalTrials.gov (NCT04084483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.