Back to resultsA Phase II Study of KCT-0809 in Patients With Dry Eye Syndrome
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KCT-0809
KCT-0809
Placebo
Sponsored by
About this trial
This is an interventional treatment 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
- Japan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
KCT-0809 ophthalmic solution, low dose
KCT-0809 ophthalmic solution, high dose
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Corneal staining score
Secondary Outcome Measures
Conjunctival staining score
Full Information
NCT ID
NCT01427816
First Posted
September 1, 2011
Last Updated
October 29, 2013
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01427816
Brief Title
A Phase II Study of KCT-0809 in Patients With Dry Eye Syndrome
Official Title
A Randomized, Double Blind, Placebo Controlled, Phase II Study of KCT-0809 in Patients With Dry Eye Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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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
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndrome.
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
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
180 (false)
8. Arms, Groups, and Interventions
Arm Title
KCT-0809 ophthalmic solution, low dose
Arm Type
Experimental
Arm Title
KCT-0809 ophthalmic solution, high dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
KCT-0809
Intervention Type
Drug
Intervention Name(s)
KCT-0809
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Corneal staining score
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Conjunctival staining score
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katsumi Hontani
Organizational Affiliation
Clinical Development Department, Kissei pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Japan
City
Tokyo and Other Japanese City
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study of KCT-0809 in Patients With Dry Eye Syndrome
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