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Clinical Trials/NCT02503176
NCT02503176
Terminated
Phase 3

An Extension Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome

Overview

Phase
Phase 3
Intervention
KCT-0809 ophthalmic solution
Conditions
Dry Eye With Sjögren's Syndrome
Sponsor
Kissei Pharmaceutical Co., Ltd.
Primary Endpoint
Incidences of adverse events
Status
Terminated
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this study is to evaluate of the long-term safety and efficacy of KCT-0809 in dry eye patients with Sjögren's syndrome.

Registry
clinicaltrials.gov
Start Date
July 20, 2015
End Date
May 29, 2017
Last Updated
8 years ago
Study Type
Interventional
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Dry eye patients with Sjögren's syndrome finished KCT1301 study

Exclusion Criteria

  • Patients with poor adherence to medication of study drug in KCT1301 study

Arms & Interventions

KCT-0809

Intervention: KCT-0809 ophthalmic solution

Outcomes

Primary Outcomes

Incidences of adverse events

Time Frame: 52 weeks

Secondary Outcomes

  • Score of the corneal staining(52 weeks)

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