Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects
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|ClinicalTrials.gov Identifier: NCT00824070|
Recruitment Status : Completed
First Posted : January 16, 2009
Results First Posted : October 29, 2010
Last Update Posted : December 13, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cataract Extraction||Drug: Besifloxacin hydrochloride Drug: moxifloxacin hydrochloride Drug: gatifloxacin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Randomized Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects After a Single Topical Dose|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||August 2009|
Besifloxacin ophthalmic suspension
Drug: Besifloxacin hydrochloride
Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
Other Name: Besivance
Active Comparator: Moxifloxacin
Vigamox (moxifloxacin ophthalmic solution, 0.5%)
Drug: moxifloxacin hydrochloride
Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
Other Name: Vigamox
Active Comparator: Gatifloxacin
Zymar (gatifloxacin ophthalmic solution, 0.3%)
Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
Other Name: Zymar
- The Aqueous Humor Drug Concentration. [ Time Frame: Visit 2, 1-14 days following screening visit ]An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824070
|United States, New York|
|Ophthalmic Consultants of Long Island|
|Rockville Center, New York, United States, 11570|
|Principal Investigator:||Eric Donnefeld||Ophthalmic Consultants of Long Island|