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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00721656
First Posted: July 24, 2008
Last Update Posted: March 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kissei Pharmaceutical Co., Ltd.
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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

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

Primary Outcome Measures:
  • Corneal-conjunctival staining [ Time Frame: 4 weeks ]

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00721656     History of Changes
Other Study ID Numbers: KLS1201
First Submitted: July 22, 2008
First Posted: July 24, 2008
Last Update Posted: March 18, 2009
Last Verified: March 2009

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