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Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes
This study is currently recruiting participants.
Verified by Kissei Pharmaceutical Co., Ltd., July 2008
Sponsored by: Kissei Pharmaceutical Co., Ltd.
Information provided by: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00721656
  Purpose

To evaluate the efficacy and safety of KLS-0611 compared to placebo in patients with dry eye syndromes.


Condition Intervention Phase
Dry Eye Syndromes
 Drug: Placebo
Drug: KLS-0611
 Phase II

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double Blind, Placebo Controlled, Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes

Further study details as provided by Kissei Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Corneal-conjunctival staining [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Arms Assigned Interventions
Placebo: Placebo Comparator Drug: Placebo
KLS-0611: Experimental Drug: KLS-0611

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721656

Contacts
Contact: Kissei Pharmaceutical Co., Ltd rinsyousiken@pharm.kissei.co.jp

Locations
Japan
Japan Recruiting
Hokkaido region, Japan
Japan Recruiting
Kanto region, Japan
Japan Recruiting
Kansai region, Japan
Japan Recruiting
Shikoku region, Japan
Japan Recruiting
Kyushu region, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
Study Director: Yasuhiro Omori Kissei Pharmaceutical Co., Ltd.
  More Information

Study ID Numbers: KLS1201
Study First Received: July 22, 2008
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00721656  
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Dry eye syndromes
Corneal diseases
Conjunctival Diseases

Study placed in the following topic categories:
Corneal Diseases
Eye Diseases
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Conjunctival Diseases

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009



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