A Parallel Group Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes
A Randomized, Double Blind, Placebo Controlled, Parallel Group Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2012
CompletedFirst Posted
Study publicly available on registry
September 25, 2012
CompletedMay 30, 2014
May 1, 2014
September 20, 2012
May 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Score of the Corneal conjunctival staining
Study Arms (2)
KCT-0809 ophtalmic solution
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Corneal and conjunctival damage
- Insufficiency of lacrimal secretion
- Ocular symptom
You may not qualify if:
- Severe ophthalmic disorder
- Punctual plugs or surgery for occlusion of the lacrimal puncta
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Japan
Tokyo and Other Japanese City, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 20, 2012
First Posted
September 25, 2012
Last Updated
May 30, 2014
Record last verified: 2014-05