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

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.
ClinicalTrials.gov Identifier: NCT00721656
Recruitment Status : Completed
First Posted : July 24, 2008
Last Update Posted : March 18, 2009
Information provided by:
Kissei Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: Placebo Drug: KLS-0611 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Experimental: KLS-0611 Drug: KLS-0611

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

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

ClinicalTrials.gov Identifier: NCT00721656     History of Changes
Other Study ID Numbers: KLS1201
First Posted: July 24, 2008    Key Record Dates
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:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Pathologic Processes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases