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NCT Number: NCT05403827

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

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.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The University of Alabama at Birmingham School of Optometry, Clinical Eye Research Center, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

K-161

Drug

K-161 Ophthalmic Solution

Placebo

Drug

Vehicle Solution

Primary outcomes

  1. Change in EDS (VAS) From Baseline to Day 85

    Time frame: Baseline to Day 85

    • Eye Dryness Score (EDS) on Visual analog scale (VAS)
    • Participant self rated level of severity where, 0 mm corresponds to "None" and 100 mm corresponds to "Worst Possible".

  2. Change in Conjunctival Sum Fluorescein Staining Score From Baseline to Day 85 (Study Eye)

    Time frame: Baseline to Day 85

    • Assessed by expanded National Eye Institute (NEI) scale
    • Conjunctival sum will be assessed as the sum of points in 6 conjunctival zones, and each zone will be graded on a 5-point scale from 0 - no conjunctival staining to 4 - severe staining of the area (0.5 increments would be allowed)
    • Minimum is 0 and maximum is 24 for Conjunctival Sum Fluorescein Staining Score.

Secondary outcomes

  1. Change From Baseline to Day 85 in Total Eye Sum Fluorescein Staining Score (Study Eye)

    Time frame: Baseline to Day 85

    • Assessed by expanded National Eye Institute (NEI) scale.
    • Total eye sum will be assessed as the sum of Corneal sum fluorescein staining score and conjunctival sum fluorescein staining score.
    • Minimum is 0 and maximum is 44 for Total Eye Sum Fluorescein Staining Score.

  2. Change From Baseline to Day 85 in Corneal Sum Fluorescein Staining Score (Study Eye)

    Time frame: Baseline to Day 85

    • Assessed by expanded National Eye Institute (NEI) scale.
    • Corneal sum will be assessed as the sum of points in 5 corneal zones, and each zone will be graded on a 5-point scale from 0 - no punctate stain in the area to 4 - Severe diffuse (coalescent) macropunctate stain of the area (0.5 increments would be allowed)
    • Minimum is 0 and maximum is 20 for Corneal Sum Fluorescein Staining Score

  3. Change From Baseline to Day 85 in Ocular Surface Disease Index Score (OSDI©)

    Time frame: Baseline to Day 85

    OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.

  4. Change From Baseline to Day 85 in Schirmer's Test (Unanesthetized) (Study Eye)

    Time frame: Baseline to Day 85

    Length (mm) of the moistened area assessed by inserting a Schirmer test strip into the eye for 5 minutes to measure the production of tears.

  5. Change From Baseline to Day 85 in Tear Film Break-up Time (TFBUT) (Study Eye)

    Time frame: Baseline to Day 85

    The time (in seconds) taken for the first dry spot to appear on the cornea after a complete blink (with the aid of a slit-lamp).

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 3, 2022
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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