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Bioequivalence of Eye Drops and Spray Administration of Vigamox

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00666042
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : January 19, 2012
Sponsor:
Information provided by:
Advanced Ophthalmic Pharma

Study Description
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Brief Summary:
The study compares the amounts of Vigamox absorbed when administered as eye drops or in a spray form. Both administrations will be prior to patients undergoing elective cataract surgery and the aqueous samples will be analyzed by a laboratory in a masked fashion. The hypothesis is that there will be no difference between the 2 modes of administration.

Condition or disease Intervention/treatment Phase
Cataract Drug: Vigamox - administration in spray form Drug: Vigamox eye drops Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Laboratory-masked, Randomized Parallel, Comparative, Pilot Study on the Bioavailability of Vigamox in the Aqueous Humor When Administered Either as Commercially Available Eye Drops or in a Spray Form
Study Start Date : February 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Experimental: A
Vigamox delivered as spray
 Drug: Vigamox - administration in spray form
Vigamox will be administered in a spray form
Active Comparator: B
Patients will receive the commercially available Vigamox drops
 Drug: Vigamox eye drops
Vigamox eye drops


Outcome Measures
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Primary Outcome Measures :
  1. Bioequivalency between the 2 ways of administration [ Time Frame: 4 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for elective cataract surgery

Exclusion Criteria:

  • Allergy to Vigamox
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): NCT00666042


Locations
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Israel
Dept. of Ophthalmology, TAMC
Tel Aviv, Israel, 69089
Sponsors and Collaborators
Advanced Ophthalmic Pharma
Investigators
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Principal Investigator: Adi Michaeli, MD TAMC, Tel Aviv, Israel
More Information
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Responsible Party: Dr. Adi Michaeli/Principal Investigator, Tel Aviv Medical Center
ClinicalTrials.gov Identifier: NCT00666042    
Other Study ID Numbers: Eye drops vs. spray
different administrations
First Posted: April 24, 2008    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: August 2009
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Moxifloxacin
Ophthalmic Solutions
Norgestimate, ethinyl estradiol drug combination
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female