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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00389025
Other study ID # C-05-30
Secondary ID
Status Completed
Phase Phase 4
First received October 13, 2006
Last updated November 18, 2016
Start date October 2006

Study information

Verified date January 2010
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To assess the effects of olopatadine of the release of mast cell histamine


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date
Est. primary completion date April 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Asymptomatic and not using any topical or systemic medication

Exclusion Criteria:

- Age

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Intervention

Drug:
Olopatadine (generic name)


Locations

Country Name City State
Italy Padova Site Padova

Sponsors (1)

Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tear histamine
Secondary Tear cytology, subject evaluation of ocular itching, investigators evaluation of ocular redness
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