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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01890941
First received: June 27, 2013
Last updated: October 16, 2015
Last verified: October 2015
  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 ]

Primary Completion Date: March 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890941

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

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: October 16, 2015
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
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on May 24, 2016