Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
|Official Title:||Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification|
- Drug concentration levels and pharmacokinetics in aqueous humor samples. [ Time Frame: Measured after 3 days of drug instillation ] [ Designated as safety issue: No ]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 will minimally include the area under the curve and the maximum concentration.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Active Comparator: VIGAMOX
Subjects undergoing cataract surgery, randomized to the VIGAMOX group
One drop 4 times daily for 3 days and one drop the day of sample collection
Active Comparator: Besivance
Subjects scheduled for cataract surgery, randomized to the Besivance group
One drop 4 times daily for 3 days and one drop on day of sample collection
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.
|Contact: Ruth Evans, C.O.T.||570-825-5949||Ruth@buccivision.com|
|Contact: Barbara Michalek||570-825-5949||Barb@buccivision.com|
|United States, Pennsylvania|
|Bucci Laser Vision Institute||Recruiting|
|Wilkes-Barre, Pennsylvania, United States, 18702|
|Contact: Ruth Evans 570-825-5949 Ruth@buccivision.com|
|Contact: Barbara Michalek 570-825-5949 Barb@buccivision.com|
|Principal Investigator:||Frank A. Bucci, Jr., MD||Bucci Laser Vision Institute|