Study of Ocular Penetration of Topically Administered Fluoroquinolones
|ClinicalTrials.gov Identifier: NCT00924729|
Recruitment Status : Completed
First Posted : June 19, 2009
Results First Posted : March 11, 2010
Last Update Posted : October 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cataract Extraction||Drug: Moxifloxacin 0.5% ophthalmic solution Drug: Besifloxacin 0.6% ophthalmic suspension||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Parallel-group Study of Ocular Penetration of Peri-operative Topically Administered Fluoroquinolones With Cataract Surgery|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||November 2009|
|Active Comparator: Moxifloxacin 0.5% ophthalmic solution||
Drug: Moxifloxacin 0.5% ophthalmic solution
Administer moxifloxacin study drug prior to cataract surgery.
Other Name: Vigamox
|Active Comparator: Besifloxacin 0.6% ophthalmic suspension||
Drug: Besifloxacin 0.6% ophthalmic suspension
Administer besifloxacin study drug prior to cataract surgery.
Other Name: Besivance
- Aqueous Humor Concentration of Study Drug [ Time Frame: approximately 3 to 4 months ]Patients were randomly assigned to receive one drop of either moxifloxacin or besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30 minutes prior to the time of the cataract incision. The aqueous humor was corrected through the paracentesis site. The specimen was transferred immediately to a polypropylene tube and stored upright at ≤ 20° C. Moxifloxacin and besifloxacin concentrations in the aqueous humor were determined using a validated high performance liquid chromatography (HPLC)-tandem mass spectrometry method.
- Disk Diffusion Assay of Collected Aqueous Humor [ Time Frame: Approximately 3-4 months. ]A disk diffusion assay was performed to determine the relative antimicrobial activity of the study drug in the aqueous humor. The reference organism used was a clinical isolate of S. epidermidis that will be grown and adjusted to a 0.5 MacFarland turbidity standard. The standardized suspension was inoculated onto a Mueller-Hinton II agar. A sample of the aqueous humor was applied to 6 mm sterile disks, dried, and then placed onto the inoculated Mueller-Hinton II agar plates. The plates were incubated for 24 hours at 35° C. The zone sizes were then recorded.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924729
|United States, Maryland|
|The Wilmer Eye Institute at Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Walter J. Stark, M.D.||The Wilmer Eye Institute|