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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02503189 |
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Date of registration:
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17/07/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome
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Scientific title:
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Date of first enrolment:
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November 23, 2016 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02503189 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Japan
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Dry eye patients with Sjögren's syndrome
- Corneal and conjunctival damage
Exclusion Criteria:
- Severe ophthalmic disorder
- Punctal plugs or surgery for occlusion of the lacrimal puncta
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dry Eye With Sjögren's Syndrome
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Intervention(s)
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Drug: Placebo
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Drug: KCT-0809 ophthalmic solution
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Primary Outcome(s)
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Score of the corneal staining
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Score of the conjunctival staining
[Time Frame: 12 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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