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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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19 February 2015 |
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Main ID: |
NCT01278784 |
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Date of registration:
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20/12/2010 |
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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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Local Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers
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Scientific title:
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Local Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers |
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Date of first enrolment:
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March 2011 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01278784 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Austria
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men and women aged between 18 and 45 years
- Normal laboratory values unless the investigator considers an abnormality to be
clinically irrelevant
- Normal findings in the medical history and physical examination unless the
investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropia < 6 dpt
Exclusion Criteria:
- Participation in a clinical trial in the 3 weeks preceding the study
- Abuse of alcoholic beverages
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Ametropia less than 6 dpt
- Pregnancy
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dry Eye Syndromes
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Intervention(s)
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Device: 0.05% Chitosan-N-Acetylcysteine eye drops
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Device: 0.1% Chitosan-N-Acetylcysteine eye drops
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Primary Outcome(s)
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Difference between 0.05% and 0.1% Chitosan-N-Acetylcysteine eye drops
[Time Frame: 6 weeks]
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Secondary ID(s)
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OPHT-141010
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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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