Back to resultsA Late Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KCT-0809 ophthalmic solution
Placebo
Sponsored by
About this trial
This is an interventional trial for Dry Eye Syndromes focused on measuring Dry eye syndromes, Corneal diseases, Conjunctival diseases
Eligibility Criteria
Inclusion Criteria:
- Corneal and conjunctival damage
- Insufficiency of lacrimal secretion
- Ocular symptom
Exclusion Criteria:
- Severe ophthalmic disorder
- Punctual plugs or surgery for occlusion of the lacrimal puncta
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
KCT-0809 Lower Dose
KCT-0809 Higher Dose
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Score of the Corneal conjunctival staining
Secondary Outcome Measures
Incidences of Adverse Events
Full Information
NCT ID
NCT01890941
First Posted
June 27, 2013
Last Updated
October 16, 2015
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01890941
Brief Title
A Late Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
March 2014 (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 evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndromes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
Dry eye syndromes, Corneal diseases, Conjunctival diseases
7. Study Design
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Arm Title
KCT-0809 Lower Dose
Arm Type
Experimental
Arm Title
KCT-0809 Higher Dose
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 conjunctival staining
Time Frame
8weeks
Secondary Outcome Measure Information:
Title
Incidences of Adverse Events
Time Frame
8weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Eligibility Criteria
Inclusion Criteria:
Corneal and conjunctival damage
Insufficiency of lacrimal secretion
Ocular symptom
Exclusion Criteria:
Severe ophthalmic disorder
Punctual 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 Late Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes
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