Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes

This study has been completed.
Sponsor:
Information provided by:
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00721656
First received: July 22, 2008
Last updated: March 16, 2009
Last verified: March 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled, Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes

Resource links provided by NLM:


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 Comparator: Placebo Drug: Placebo
Experimental: KLS-0611 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721656

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

No publications provided

ClinicalTrials.gov Identifier: NCT00721656     History of Changes
Other Study ID Numbers: KLS1201
Study First Received: July 22, 2008
Last Updated: March 16, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on September 18, 2014