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

History of Changes

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:

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Tobramycin Tobramycin sulfate Dexamethasone acetate

U.S. FDA Resources

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 (Adult, Senior)
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


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:


Cataract Lens Diseases Eye Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Tobramycin Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents	Physiological Effects of Drugs 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 23, 2016

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