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A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease

Sponsor
Kowa Research Institute, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05403827
Collaborator
(none)
620
Enrollment
1
Location
2
Arms
16
Anticipated Duration (Months)
38.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy and safety of K-161 ophthalmic solution for the treatment of moderate to severe dry eye disease.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
620 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Prospective, Double-masked, Randomized, Multi-center, Vehicle-controlled, Parallel-group, 12-week Administration and 40-week Extension Study Confirming the Efficacy and Safety of K-161 Ophthalmic Solution for the Treatment of Moderate to Severe Dry Eye Disease
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: K-161

K-161 Ophthalmic Solution

Drug: K-161
K-161 Ophthalmic Solution
Placebo Comparator: Placebo

Vehicle Solution

Drug: Placebo
Vehicle Solution

Outcome Measures

Primary Outcome Measures

  1. Change in eye dryness score (EDS) [Baseline to Day 85]

  2. Change in conjunctival sum fluorescein staining score. [Baseline to Day 85]

Secondary Outcome Measures

  1. Change in total eye sum fluorescein staining score [Baseline to Day 85]

  2. Change in corneal sum fluorescein staining score [Baseline to Day 85]

  3. Change in ocular surface disease index (OSDI) [Baseline to Day 85]

    Questionnaire

  4. Change in Schirmer's test [Baseline to Day 85]

    Assessed by Schirmer Tear Test (length of moistened area (mm))

  5. Change in tear film break-up time (TFBUT) [Baseline to Day 85]

    TFBUT will be assessed using fluorescein solution and measured in seconds

  6. Safety and Tolerability of K-161 in participants with DED [Baseline to Day 85]

    Safety and tolerability measured in terms of the number of treatment related adverse events (TEAEs)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Be at least 18 years of age at the time of Informed Consent

  • Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptom

  • Meet all other 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

  • Meet any other exclusion criteria outlined in the clinical study protocol

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lake Travis Eye and Laser Center / Revolution Research Lakeway Texas United States 78738

Sponsors and Collaborators

  • Kowa Research Institute, Inc.

Investigators

  • Study Chair: Andrey E. Belous, MD, PhD, Kowa Pharma Development Co.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT05403827
Other Study ID Numbers:
  • K-161-3.01
First Posted:
Jun 3, 2022
Last Update Posted:
Jun 3, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases

Study Results

No Results Posted as of Jun 3, 2022