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Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification

Cataracts Clinical Trial

Official title:
Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification

Clinical Trial Summary

The purpose of this study is to compare drug concentrations in aqueous humor following ocular instillation of Besivance and VIGAMOX in subjects undergoing cataract surgery.

Clinical Trial Description

The objective of this study is to compare drug concentrations in aqueous humor following ocular instillation of Besivance or VIGAMOX in subjects undergoing cataract surgery. The hypothesis of the study is that the aggregate aqueous absorption of Besivance over a six hour period is greater than VIGAMOX because of unique properties of Besivance which promote increased contact time of this antibiotic with the ocular surface. Subjects with scheduled cataract surgery will be screened during their pre-operative visit. Eligible subjects will be randomized to treatment with Besivance or VIGAMOX. Subjects will self-administer 1 drop of study drug into the operative eye 4 times a day for 3 days prior to surgery.Subjects will have one final drop of study medication on the day of surgery.Immediately prior to beginning the cataract surgery, a sample of aqueous humor will be collected by paracentesis.Concentration of Besivance and VIGAMOX in the aqueous humor will be determined by an independent laboratory using standardized high pressure liquid chromatography and mass spectrometry assays. Pharmacokinetic parameters determined from the aqueous humor concentration-time data will minimally include the area under the curve and the maximum concentration. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01296191
Study type Interventional
Source Bucci Laser Vision Institute
Contact
Status Completed
Phase Phase 4
Start date May 2011
Completion date January 2013
View Details
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