Study of Ocular Penetration of Topically Administered Fluoroquinolones
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|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.
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): 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|