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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2020


  • Drug: K-161
    • K-161 alternate dosage
  • Other: Placebo (Vehicle)
    • Placebo solution

Arms, Groups and Cohorts

  • Experimental: Group 1
    • K-161 Ophthalmic Solution Dose A.
  • Experimental: Group 2
    • K-161 Ophthalmic Solution Dose B.
  • Experimental: Group 3
    • K-161 Ophthalmic Solution Dose C.
  • Placebo Comparator: Group 4
    • Vehicle Solution Dose.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Inferior Corneal Staining
    • Time Frame: 29 Days
    • K-161 compared to Vehicle
  • Change in Ocular Discomfort
    • Time Frame: 29 Days
    • Questionnaire

Secondary Measures

  • Change in Schirmer’s Test value
    • Time Frame: 29 Days
  • Change in Tear Film break-up Time (TFBUT)
    • Time Frame: 29 Days
  • Number of Participants with Treatment Emergent Adverse Events
    • Time Frame: 29 Days

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kowa Research Institute, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Director, Clinical Operations, 919-433-1621, StudyRecruitment@KowaUS.com

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