A Bioequivalence Study of Tobradex AF

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00362895
Collaborator
(none)
995
1
2
4
248.2

Study Details

Study Description

Brief Summary

The purpose of the study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension
  • Drug: Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
995 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Double-Masked, Parallel-Group, Randomized, Single-Dose Bioequivalence Study of Tobradex AF Suspension and TOBRADEX Ophthalmic Suspension
Study Start Date :
Apr 1, 2006
Actual Primary Completion Date :
Aug 1, 2006
Actual Study Completion Date :
Aug 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tobradex AF

Drug: Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension
One drop in the study eye, single dose

Active Comparator: TOBRADEX

Drug: Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)
One drop in the study eye, single dose
Other Names:
  • TOBRADEX®
  • Outcome Measures

    Primary Outcome Measures

    1. Concentration of dexamethasone in aqueous humor following a single topical ocular administration []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 18 or older

    • Other protocol-defined inclusion criteria may apply

    Exclusion Criteria:
    • Under 18

    • Other protocol-defined exclusion criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Contact Alcon for Trial Location(s) Fort Worth Texas United States 76134

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT00362895
    Other Study ID Numbers:
    • C-05-23
    First Posted:
    Aug 15, 2006
    Last Update Posted:
    Mar 5, 2012
    Last Verified:
    Mar 1, 2012

    Study Results

    No Results Posted as of Mar 5, 2012