A Bioequivalence Study of Tobradex AF

Overview

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.

Full Title of Study: “A Double-Masked, Parallel-Group, Randomized, Single-Dose Bioequivalence Study of Tobradex AF Suspension and TOBRADEX Ophthalmic Suspension”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2006

Interventions

  • Drug: Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension
    • One drop in the study eye, single dose
  • Drug: Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)
    • One drop in the study eye, single dose

Arms, Groups and Cohorts

  • Experimental: Tobradex AF
  • Active Comparator: TOBRADEX

Clinical Trial Outcome Measures

Primary Measures

  • Concentration of dexamethasone in aqueous humor following a single topical ocular administration

Participating in This Clinical Trial

Inclusion Criteria

  • 18 or older
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria

  • Under 18
  • Other protocol-defined exclusion criteria may apply

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alcon Research
  • Provider of Information About this Clinical Study
    • Sponsor

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