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A Study of KCT-0809 in Patients With Dry Eye Syndromes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01211951
First Posted: September 30, 2010
Last Update Posted: July 4, 2011
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
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 Intervention Phase
Dry Eye Syndromes Drug: KCT-0809 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled, Exploratory Phase II Study of KCT-0809 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 scores [ Time Frame: 4 weeks ]

Estimated Enrollment: 160
Arms Assigned Interventions
Experimental: KCT-0809 ophthalmic solution, low dose Drug: KCT-0809
Experimental: KCT-0809 ophthalmic solution, medium dose Drug: KCT-0809
Experimental: KCT-0809 ophthalmic solution, high dose Drug: KCT-0809
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

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 or tear film instability
  • 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): NCT01211951


Locations
Japan
Japan
Tohoku, Kanto, Chubu, Kansai, Kyushu region, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
Study Director: Katsumi Hontani Kissei Pharmaceutical Co., Ltd.
  More Information

ClinicalTrials.gov Identifier: NCT01211951     History of Changes
Other Study ID Numbers: KCT1201
First Submitted: September 26, 2010
First Posted: September 30, 2010
Last Update Posted: July 4, 2011
Last Verified: June 2011

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