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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01427816
First received: September 1, 2011
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

To evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndrome.


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, Phase II Study of KCT-0809 in Patients With Dry Eye Syndrome

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Corneal staining score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Conjunctival staining score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Arms Assigned Interventions
Experimental: KCT-0809 ophthalmic solution, low 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
  • 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: NCT01427816

Locations
Japan
Japan
Tokyo and Other Japanese City, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
Study Director: Katsumi Hontani Clinical Development Department, Kissei pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01427816     History of Changes
Other Study ID Numbers: KCT1202
Study First Received: September 1, 2011
Last Updated: October 29, 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
Syndrome
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Disease
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Pathologic Processes
Ophthalmic Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014