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A Late 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: NCT01890941
Recruitment Status : Completed
First Posted : July 2, 2013
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

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 ophthalmic solution Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Primary Completion Date : March 2014

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: KCT-0809 Lower Dose Drug: KCT-0809 ophthalmic solution
Experimental: KCT-0809 Higher Dose Drug: KCT-0809 ophthalmic solution
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Score of the Corneal conjunctival staining [ Time Frame: 8weeks ]

Secondary Outcome Measures :
  1. Incidences of Adverse Events [ Time Frame: 8weeks ]


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
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

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): NCT01890941


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

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01890941     History of Changes
Other Study ID Numbers: KCT1205
First Posted: July 2, 2013    Key Record Dates
Last Update Posted: October 19, 2015
Last Verified: October 2015

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
Ophthalmic Solutions
Pharmaceutical Solutions