Back to resultsA Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome
Primary Purpose
Dry Eye With Sjögren's Syndrome
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KCT-0809 ophthalmic solution
Placebo
Sponsored by
About this trial
This is an interventional trial for Dry Eye With Sjögren's Syndrome focused on measuring Dry eye syndromes, Corneal diseases, Conjunctival diseases
Eligibility Criteria
Inclusion Criteria:
- Dry eye patients with Sjögren's syndrome
- Corneal and conjunctival damage
Exclusion Criteria:
- Severe ophthalmic disorder
- Punctal plugs or surgery for occlusion of the lacrimal puncta
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
KCT-0809
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Score of the corneal staining
Secondary Outcome Measures
Score of the conjunctival staining
Full Information
NCT ID
NCT02503189
First Posted
July 17, 2015
Last Updated
May 15, 2017
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02503189
Brief Title
A Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
January 2017 (Actual)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to investigate the superiority of KCT-0809 to placebo, and to evaluate safety in dry eye patients with Sjögren's syndrome
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye With Sjögren's Syndrome
Keywords
Dry eye syndromes, Corneal diseases, Conjunctival diseases
7. Study Design
Study Phase
Phase 3
8. Arms, Groups, and Interventions
Arm Title
KCT-0809
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
KCT-0809 ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Score of the corneal staining
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Score of the conjunctival staining
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Eligibility Criteria
Inclusion Criteria:
Dry eye patients with Sjögren's syndrome
Corneal and conjunctival damage
Exclusion Criteria:
Severe ophthalmic disorder
Punctal plugs or surgery for occlusion of the lacrimal puncta
Facility Information:
City
Tokyo and Other Japanese City
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome
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