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
Drug: Vigamox - administration in spray form
Drug: Vigamox eye drops

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
Health Authority: Israel: Ethics Commission

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Vasoconstrictor Agents processed this record on May 26, 2016