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

This study is currently recruiting participants.
Verified June 2013 by Kissei Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01890941
First received: June 27, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  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 ophthalmic solution
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study

Resource links provided by NLM:


Further study details as provided by Kissei Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Score of the Corneal conjunctival staining [ Time Frame: 8weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidences of Adverse Events [ Time Frame: 8weeks ] [ Designated as safety issue: Yes ]

Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01890941

Contacts
Contact: Kissei Pharmaceutical Co., Ltd rinsyousiken@pharm.kissei.co.jp

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

No publications provided

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01890941     History of Changes
Other Study ID Numbers: KCT1205
Study First Received: June 27, 2013
Last Updated: June 27, 2013
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