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Completed

NCT Number: NCT04084483

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

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.

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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 2

Primary location

Eye Research Foundation, Newport Beach, California, United States

Loading trial locations.

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 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.

Treatment and study plan

K-161

Drug

K-161 alternate dosage

Placebo (Vehicle)

Other

Placebo solution

Primary outcomes

  1. 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.

  2. 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

  1. Change in Schirmer's Test Value (Unanesthetized) Pre-CAE

    Time frame: Baseline to Day 29

    Measured with Schirmer's test strip with the length of the moistened area recorded in mm. Lower values indicate less tears produced in the eye.

  2. Change in Tear Film Break-up Time (TFBUT) Post-CAE

    Time frame: Baseline to Day 29

  3. Change in Fluorescein Staining Scores (Pre-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.

  4. Change in Lissamine Green Staining (Pre-CAE) Using the Ora Calibra® Scale (Conjunctival Sum)

    Time frame: Baseline to Day 29

    Ora Calibra Scale which is 0 to 4 scale with increasing half-units and where higher numbers indicating more severe staining.

  5. Change in Conjunctival Redness (Pre-CAE)

    Time frame: Baseline to Day 29

    Conjunctival Redness Scale ranges from 0 to 4, where 0 = normal, without vasodilation and 4 = Broad Ciliary and Prominent, Horizontal Conjunctival Vasodilation. Higher scores indicate worsening conjunctival redness.

  6. Change in Tear Film Break-Up Time (Pre CAE)

    Time frame: Baseline to Day 29

  7. Change in Tear Osmolarity (Pre CAE)

    Time frame: Baseline to Day 29

  8. Change in Unanesthetized Schirmer's Test (Pre CAE)

    Time frame: Baseline to Day 29

    Measured with Schirmer's test strip with the length of the moistened area recorded in mm. Lower values indicate less tears produced in the eye.

  9. Change in Blink Rate (Pre CAE)

    Time frame: Baseline to Day 29

    Blinks per 60 seconds.

  10. Change in Ocular Discomfort Scale (Pre CAE)

    Time frame: Baseline to Day 29

    Ora Calibra® Ocular Discomfort Scale ranging from 0 to 4

  11. Change in Ocular Discomfort and 4-Symptom Questionnaire (Pre CAE)

    Time frame: Baseline to Day 29

    Scores ranging from 0 to 5. A score of 0 indicates no discomfort/symptoms and a score of 5 indicates worst discomfort/symptoms.

  12. Change in Visual Analog Scale (Pre CAE)

    Time frame: Baseline to Day 29

    The length of the assessment line was 100 mm; a measure of 0 mm corresponded to "no discomfort" and 100 mm corresponds to "maximal discomfort".

  13. Change in Ocular Surface Disease Index Score (Pre-CAE) - Total OSDI

    Time frame: Baseline to Day 29

    The OSDI© is comprised of 12 questions, with each question assessed on a scale ranging from 0 to 4 where 0 = none of the time, 1 = some of the time, 2 = half of the time, 3 = most of the time, and 4 = all of the time. The range of total score is "0 to 100". "Subscale" scores are not reported. Higher score represents a worsen outcome. The total score is the sum of subscales.

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2019
Registry last updated
Mar 15, 2023

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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