An Extension Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome
Phase 3
Terminated
- Conditions
- Dry Eye With Sjögren's Syndrome
- Interventions
- Drug: KCT-0809 ophthalmic solution
- Registration Number
- NCT02503176
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Dry eye patients with Sjögren's syndrome finished KCT1301 study
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Exclusion Criteria
- Patients with poor adherence to medication of study drug in KCT1301 study
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description KCT-0809 KCT-0809 ophthalmic solution -
- Primary Outcome Measures
Name Time Method Incidences of adverse events 52 weeks
- Secondary Outcome Measures
Name Time Method Score of the corneal staining 52 weeks