- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00721656
Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes
March 16, 2009 updated by: Kissei Pharmaceutical Co., Ltd.
A Randomized, Double Blind, Placebo Controlled, Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes
To evaluate the efficacy and safety of KLS-0611 compared to placebo in patients with dry eye syndromes.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hokkaido region, Japan
- Japan
-
Kansai region, Japan
- Japan
-
Kanto region, Japan
- Japan
-
Kyushu region, Japan
- Japan
-
Shikoku region, Japan
- Japan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: KLS-0611
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Corneal-conjunctival staining
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
July 22, 2008
First Submitted That Met QC Criteria
July 23, 2008
First Posted (Estimate)
July 24, 2008
Study Record Updates
Last Update Posted (Estimate)
March 18, 2009
Last Update Submitted That Met QC Criteria
March 16, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KLS1201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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