Status:
COMPLETED
A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease
Lead Sponsor:
Kowa Research Institute, Inc.
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2020
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT04084483
Start Date
August 4 2019
End Date
January 9 2020
Last Update
March 15 2023
Active Locations (4)
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1
Eye Research Foundation
Newport Beach, California, United States, 92663
2
Central Maine Eye Care
Lewiston, Maine, United States, 04240
3
Andover Eye Associates
Andover, Massachusetts, United States, 01810
4
Total Eye Care, P.A.
Memphis, Tennessee, United States, 38119