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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: |
NCT01344083 |
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Date of registration:
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21/04/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of the Efficacy and Tolerability of T1210 and Olopatadine Hydrochloride 0.1% in the Treatment of Seasonal Allergic Conjunctivitis
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Scientific title:
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Date of first enrolment:
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April 2011 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01344083 |
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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: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Written informed consent
- Conjunctivitis allergic conjunctivitis
Exclusion Criteria:
- Severe ocular allergy
- Vernal keratoconjunctivitis
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Seasonal Allergic Conjunctivitis
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Intervention(s)
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Drug: Olopatadine hydrochloride
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Drug: T1210
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Primary Outcome(s)
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Change from baseline of the score of tearing
[Time Frame: Day 28]
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Change from baseline of the score of conjunctival hyperaemia
[Time Frame: Day 28]
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Change from baseline of the score of itching
[Time Frame: Day 28]
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Secondary Outcome(s)
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Global local tolerance assessment by the Investigator and the patient
[Time Frame: Day 7]
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Global local tolerance assessment by the Investigator and the patient
[Time Frame: Day 28]
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Secondary ID(s)
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LT1210-PII-04/10
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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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