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Trial record 13 of 52 for:    cataract AND ophthalmic suspension

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
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Condition Cataract Extraction
Interventions Drug: Moxifloxacin 0.5% ophthalmic solution
Drug: Besifloxacin 0.6% ophthalmic suspension
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Moxifloxacin 0.5% Ophthalmic Solution Besifloxacin 0.6% Ophthalmic Suspension
Hide Arm/Group Description The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision. The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
Period Title: Overall Study
Started 25 25
Completed 23 25
Not Completed 2 0
Reason Not Completed
insufficient volume for analysis             1             0
Protocol Violation             1             0
Arm/Group Title Moxifloxacin 0.5% Ophthalmic Solution Besifloxacin 0.6% Ophthalmic Suspension Total
Hide Arm/Group Description The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision. The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision. Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  12.0%
7
  28.0%
10
  20.0%
>=65 years
22
  88.0%
18
  72.0%
40
  80.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
74.0  (8.90) 68.0  (14.0) 71.0  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
11
  44.0%
10
  40.0%
21
  42.0%
Male
14
  56.0%
15
  60.0%
29
  58.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Aqueous Humor Concentration of Study Drug
Hide Description 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.
Time Frame approximately 3 to 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Moxifloxacin 0.5% Ophthalmic Solution Besifloxacin 0.6% Ophthalmic Suspension
Hide Arm/Group Description:
The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
Overall Number of Participants Analyzed 23 25
Mean (Standard Deviation)
Unit of Measure: µg/ml
1.6108  (0.6835) 0.0312  (0.0131)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin 0.5% Ophthalmic Solution, Besifloxacin 0.6% Ophthalmic Suspension
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Disk Diffusion Assay of Collected Aqueous Humor
Hide Description 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.
Time Frame Approximately 3-4 months.
Hide Outcome Measure Data
Hide Analysis Population Description
The amount of aqueous concentration of antibiotic agent was not enough to perform a secondary analysis
Arm/Group Title Moxifloxacin 0.5% Ophthalmic Solution Besifloxacin 0.6% Ophthalmic Suspension
Hide Arm/Group Description:
Moxifloxacin 0.5% ophthalmic solution: Administer moxifloxacin study drug prior to cataract surgery.
Besifloxacin 0.6% ophthalmic suspension: Administer besifloxacin study drug prior to cataract surgery.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Moxifloxacin 0.5% Ophthalmic Solution Besifloxacin 0.6% Ophthalmic Suspension
Hide Arm/Group Description The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision. The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
All-Cause Mortality
Moxifloxacin 0.5% Ophthalmic Solution Besifloxacin 0.6% Ophthalmic Suspension
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Moxifloxacin 0.5% Ophthalmic Solution Besifloxacin 0.6% Ophthalmic Suspension
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Moxifloxacin 0.5% Ophthalmic Solution Besifloxacin 0.6% Ophthalmic Suspension
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Walter J. Stark, M.D./Professor of Ophthalmology
Organization: Johns Hopkins University
Phone: 410-955-5490
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00924729     History of Changes
Other Study ID Numbers: NA_28692
First Submitted: June 5, 2009
First Posted: June 19, 2009
Results First Submitted: February 24, 2010
Results First Posted: March 11, 2010
Last Update Posted: October 24, 2017