Bioequivalence of Eye Drops and Spray Administration of Vigamox
Information source: Advanced Ophthalmic Pharma
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cataract
Intervention: Vigamox - administration in spray form (Drug); Vigamox eye drops (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Advanced Ophthalmic Pharma Official(s) and/or principal investigator(s):
Adi Michaeli, MD, Principal Investigator, Affiliation: TAMC, Tel Aviv, Israel
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.
Clinical Details
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 design: Other, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Bio-equivalence Study
Primary outcome: Bioequivalency between the 2 ways of administration
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients scheduled for elective cataract surgery
Exclusion Criteria:
- Allergy to Vigamox
Locations and Contacts
Dept. of Ophthalmology, TAMC, Tel Aviv 69089, Israel; Recruiting
Adi Michaeli, MD, Phone: +972-52-426-6508, Email: adi.michaeli@gmail.com
Adi Michaeli, MD, Principal Investigator
Additional Information
Starting date: February 2009
Ending date: May 2009
Last updated: February 24, 2009
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