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Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle

Primary Purpose

Post-surgical Inflammation

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tobradex (Antibiotic steroid combination)
Sponsored by
Alcon Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-surgical Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled for cataract extraction

Exclusion Criteria:

  • Under 18 years

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Anterior chamber inflammation

    Secondary Outcome Measures

    Aqueous cells and flare
    ocular pain
    physician's impression of infection
    frequency of treatment failures

    Full Information

    First Posted
    November 28, 2006
    Last Updated
    March 3, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00404937
    Brief Title
    Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle
    Official Title
    Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2007
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    December 2006 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    December 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Alcon Research

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-surgical Inflammation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Tobradex (Antibiotic steroid combination)
    Primary Outcome Measure Information:
    Title
    Anterior chamber inflammation
    Secondary Outcome Measure Information:
    Title
    Aqueous cells and flare
    Title
    ocular pain
    Title
    physician's impression of infection
    Title
    frequency of treatment failures

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients scheduled for cataract extraction Exclusion Criteria: Under 18 years

    12. IPD Sharing Statement

    Learn more about this trial

    Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle

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