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Bioequivalence of Eye Drops and Spray Administration of Vigamox

This study has been completed.
Information provided by:
Advanced Ophthalmic Pharma Identifier:
First received: April 22, 2008
Last updated: January 18, 2012
Last verified: August 2009
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 Intervention
Cataract Drug: Vigamox - administration in spray form Drug: Vigamox eye drops

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Advanced Ophthalmic Pharma:

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

Estimated Enrollment: 16
Study Start Date: February 2009
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

Inclusion Criteria:

  • Patients scheduled for elective cataract surgery

Exclusion Criteria:

  • Allergy to Vigamox
  Contacts and Locations
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Please refer to this study by its identifier: NCT00666042

Dept. of Ophthalmology, TAMC
Tel Aviv, Israel, 69089
Sponsors and Collaborators
Advanced Ophthalmic Pharma
Principal Investigator: Adi Michaeli, MD TAMC, Tel Aviv, Israel
  More Information

Responsible Party: Dr. Adi Michaeli/Principal Investigator, Tel Aviv Medical Center Identifier: NCT00666042     History of Changes
Other Study ID Numbers: Eye drops vs. spray
different administrations
Study First Received: April 22, 2008
Last Updated: January 18, 2012

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases
Ophthalmic Solutions
Norgestimate, ethinyl estradiol drug combination
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors processed this record on September 21, 2017