A Bioequivalence Study of Tobradex AF

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00362895
First received: August 9, 2006
Last updated: March 2, 2012
Last verified: March 2012
  Purpose

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
Cataract
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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362895

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

ClinicalTrials.gov processed this record on September 18, 2014