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A Bioequivalence Study of Tobradex AF

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ClinicalTrials.gov Identifier: NCT00362895
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : March 5, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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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
Cataract Drug: Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension Drug: Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : April 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006
Arms and Interventions
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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 Name: TOBRADEX®


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00362895


Locations
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United States, Texas
Contact Alcon for Trial Location(s)
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00362895    
Other Study ID Numbers: C-05-23
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Tobramycin
Tobramycin, Dexamethasone Drug Combination
Dexamethasone
Dexamethasone acetate
BB 1101
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
Ophthalmic Solutions
Pharmaceutical Solutions