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A Parallel Group Phase II Study of KCT-0809 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: NCT01692145
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : May 30, 2014
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndromes.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: KCT-0809 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled, Parallel Group Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: KCT-0809 ophtalmic solution Drug: KCT-0809
Placebo Comparator: Placebo Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. Score of the Corneal conjunctival staining

Eligibility Criteria

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
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): NCT01692145


Locations
Japan
Japan
Tokyo and Other Japanese City, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
More Information

ClinicalTrials.gov Identifier: NCT01692145     History of Changes
Other Study ID Numbers: KCT1204
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: May 30, 2014
Last Verified: May 2014

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