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Bioequivalence of Eye Drops and Spray Administration of Vigamox

Information source: Advanced Ophthalmic Pharma
ClinicalTrials.gov processed this data on August 23, 2015
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: Completed

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: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

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
Additional Information

Starting date: February 2009
Last updated: January 18, 2012

Page last updated: August 23, 2015

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