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An Extension Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02503176
Recruitment Status : Terminated (Discontinuation of the development)
First Posted : July 20, 2015
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Study Description
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Brief Summary:
The purpose of this study is to evaluate of the long-term safety and efficacy of KCT-0809 in dry eye patients with Sjögren's syndrome.

Condition or disease Intervention/treatment Phase
Dry Eye With Sjögren's Syndrome Drug: KCT-0809 ophthalmic solution Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Primary Completion Date : May 29, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: KCT-0809 Drug: KCT-0809 ophthalmic solution


Outcome Measures
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Primary Outcome Measures :
  1. Incidences of adverse events [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Score of the corneal staining [ Time Frame: 52 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Dry eye patients with Sjögren's syndrome finished KCT1301 study

Exclusion Criteria:

  • Patients with poor adherence to medication of study drug in KCT1301 study
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503176


Locations
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Japan
Multiple Locations, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
More Information
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Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02503176     History of Changes
Other Study ID Numbers: KCT1302
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Dry eye syndromes
Corneal diseases
Conjunctival diseases
Additional relevant MeSH terms:
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Sjogren's Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Syndrome
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Arthritis, Rheumatoid
 Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Ophthalmic Solutions
Pharmaceutical Solutions