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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT00331500 |
Date of registration:
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30/05/2006 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Olopatadine 0.2% for the Treatment of Allergic Conjunctivitis
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Scientific title:
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A Comparative Study of Olopatadine 0.2% Versus Vehicle in Patients With Seasonal Allergic Conjunctivitis or Rhinoconjunctivitis |
Date of first enrolment:
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April 18, 2006 |
Target sample size:
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287 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT00331500 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Alcon, A Novartis Company |
Address:
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Telephone:
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Email:
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Affiliation:
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Alcon, a Novartis Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- History of seasonal allergic conjunctivitis or rhinoconjunctivitis, a positive grass
antigen challenge reaction (skin test), and a positive response to grass in the
Conjunctival Allergen Challenge (CAC) model
Exclusion Criteria:
- Under 10 years of age
Age minimum:
10 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Allergic Conjunctivitis
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Intervention(s)
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Drug: Olopatadine Hydrochloride Ophthalmic Solution Vehicle
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Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
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Primary Outcome(s)
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Daily ocular itching and redness scores
[Time Frame: Up to Day 14]
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Secondary Outcome(s)
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Percentage of patients with daily ocular itching and redness scores of 0
[Time Frame: Up to Day 14]
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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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