Back to resultsA 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
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 or tear film instability
- 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 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
KCT-0809 ophthalmic solution, low dose
KCT-0809 ophthalmic solution, medium dose
KCT-0809 ophthalmic solution, high dose
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Corneal-conjunctival staining scores
Secondary Outcome Measures
Full Information
NCT ID
NCT01211951
First Posted
September 26, 2010
Last Updated
June 30, 2011
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01211951
Brief Title
A Study of KCT-0809 in Patients With Dry Eye Syndromes
Official Title
A Randomized, Double Blind, Placebo Controlled, Exploratory Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
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
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (false)
8. Arms, Groups, and Interventions
Arm Title
KCT-0809 ophthalmic solution, low dose
Arm Type
Experimental
Arm Title
KCT-0809 ophthalmic solution, medium 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)
KCT-0809
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Corneal-conjunctival staining scores
Time Frame
4 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 or tear film instability
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
Kissei Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Japan
City
Tohoku, Kanto, Chubu, Kansai, Kyushu region
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study of KCT-0809 in Patients With Dry Eye Syndromes
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