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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01427816
First received: September 1, 2011
Last updated: March 12, 2012
Last verified: March 2012
History of Changes
  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:

U.S. FDA Resources

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
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: March 12, 2012
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 May 19, 2013