A Bioequivalence Study of Tobradex AF

This study has been completed.
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
First received: August 9, 2006
Last updated: March 2, 2012
Last verified: March 2012
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 Intervention Phase
Drug: Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension
Drug: Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Masked, Parallel-Group, Randomized, Single-Dose Bioequivalence Study of Tobradex AF Suspension and TOBRADEX Ophthalmic Suspension

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Concentration of dexamethasone in aqueous humor following a single topical ocular administration

Enrollment: 995
Study Start Date: April 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: TOBRADEX®


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00362895

United States, Texas
Contact Alcon for Trial Location(s)
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00362895     History of Changes
Other Study ID Numbers: C-05-23
Study First Received: August 9, 2006
Last Updated: March 2, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 30, 2015