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

This study has been completed.
Sponsor:
Information provided by:
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01211951
First received: September 26, 2010
Last updated: June 30, 2011
Last verified: June 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT01211951     History of Changes
Other Study ID Numbers: KCT1201
Study First Received: September 26, 2010
Last Updated: June 30, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Dry eye syndromes
Corneal diseases
Conjunctival diseases

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on April 17, 2014