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

NCT04084483 | Completed Phase 2 Results FDA Drug

• 1 other identifier: K-161-2.01US
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 4

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.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Change in Schirmer's Test Value (Unanesthetized) 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 Lissamine Green Staining (Pre-CAE) Using the Ora Calibra® Scale (Conjunctival Sum)

  Baseline to Day 29

• Change in Conjunctival Redness (Pre-CAE)

  Baseline to Day 29

Study Arms (4)

Group 1

EXPERIMENTAL

K-161 Ophthalmic Solution Dose A.

Drug: K-161

Group 2

EXPERIMENTAL

K-161 Ophthalmic Solution Dose B.

Drug: K-161

Group 3

EXPERIMENTAL

K-161 Ophthalmic Solution Dose C.

Drug: K-161

Group 4

PLACEBO COMPARATOR

Vehicle Solution Dose.

Other: Placebo (Vehicle)

Interventions

K-161 DRUG

K-161 alternate dosage

Group 1; Group 2; Group 3

Placebo (Vehicle) OTHER

Placebo solution

Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Have any clinically significant ocular condition.
• Have a history of corneal refractive surgery and/or any other ocular surgical procedure within 12 months.

Sponsors & Collaborators

• Kowa Research Institute, Inc.: lead

Study Sites (4)

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Central Maine Eye Care

Lewiston, Maine, 04240, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Total Eye Care, P.A.

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Director, Clinical Operations
• Organization: Kowa Research Institute, Inc.

CTGResults@KowaUS.com

919-433-1600

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: September 10, 2019
• Study Start: August 4, 2019
• Primary Completion: January 9, 2020
• Study Completion: January 9, 2020
• Last Updated: March 15, 2023
• Results First Posted: March 15, 2023

Record last verified: 2023-02

Locations

US (4)