Clinical Trials Logo
  1. Home
  2. Cataracts
  3. NCT01296191

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06005675 - User Acceptability Evaluation of Pseudophakic Patients Previously Implanted With the TECNIS Odyssey IOL
Active, not recruiting NCT01382641 - Show Improved Vision With the HOYA AF-1 Aspheric Intraocular Lens After Cataract Surgery Phase 4
Completed NCT01382823 - Laser Cataract Surgery With the Femtosecond Laser Technology Phase 4
Completed NCT05991960 - Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL
Active, not recruiting NCT05574959 - Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens, Model DEN00V N/A
Completed NCT02492659 - Clinical Research of Femtosecond Laser-Assisted Cataract Surgery N/A
Completed NCT01279031 - Randomized Comparison of the Abbott WHITESTAR Signature System With Ellips Tranversal Ultrasound vs. the Alcon Infiniti With the Ozil Torsional Handpiece in Phacoemulsification: A Contralaterally-Controlled Trial Phase 4
Completed NCT01061463 - Occupational Cataracts and Lens Opacities in Interventional Cardiology : the O'CLOC Study N/A
Completed NCT01001806 - A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification Phase 4
Completed NCT00999492 - Selection of Aspheric Diffractive Multifocal Intraocular Lens (IOLS) Based on Corneal Wavefront Phase 4
Completed NCT01021761 - A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification Phase 4
Completed NCT00542581 - Acrysof Toric SN60T3corneal Astigmatism Between 0.75 and 1.00 D. N/A
Completed NCT03708367 - A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice N/A
Completed NCT05575063 - Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) N/A
Recruiting NCT05531292 - PROOF-OF-CONCEPT STUDY FOR NEW INTRAOCULAR LENS, MODEL C0002 N/A
Completed NCT05058274 - Clinical Results of a Monofocal Aspheric Bitoric Intraocular Lens With Plate Haptics in Hyperopic Eyes (HIPER-AT-TORBI)
Completed NCT05053399 - Evaluation of the TECNIS Symfony® Toric Intraocular Lens N/A
Recruiting NCT02639845 - Eye Drop Application Monitor, Pilot Study N/A
Completed NCT01684007 - A Clinical Outcome Study of Two Multifocal Intraocular Lenses (IOL) in Cataract Patients N/A
Completed NCT00827073 - Comparison of Tetracaine 0.5% and Lidocaine 2% Jelly for Topical Phacoemulsification Cataract Surgery N/A