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Trial record 8 of 19 for:    "Lens Disease" | "Estradiol"

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
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Cataract Extraction
Interventions Drug: Besifloxacin hydrochloride
Drug: moxifloxacin hydrochloride
Drug: gatifloxacin
Enrollment 105
Recruitment Details This study was conducted a 6 sites in the US. This was a single dose study with first patient enrollment on 2/2/2009 and last patient visit was 7/9/2009.
Pre-assignment Details 105 subjects were screened at Visit 1 and qualified subjects returned on the day of surgery (Visit 2).
Arm/Group Title Besifloxacin Moxifloxacin Gatifloxacin
Hide Arm/Group Description Besifloxacin ophthalmic suspension Vigamox (moxifloxacin ophthalmic solution, 0.5%) Zymar (gatifloxacin ophthalmic solution, 0.3%)
Period Title: Overall Study
Started 34 35 36
Completed 34 35 36
Not Completed 0 0 0
Arm/Group Title Besifloxacin Moxifloxacin Gatifloxacin Total
Hide Arm/Group Description Besifloxacin ophthalmic suspension Vigamox (moxifloxacin ophthalmic solution, 0.5%) Zymar (gatifloxacin ophthalmic solution, 0.3%) Total of all reporting groups
Overall Number of Baseline Participants 34 35 36 105
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 36 participants 105 participants
<60 years 4 4 5 13
60-69 years 15 7 10 32
70-79 years 11 19 14 44
>/= 80 4 5 7 16
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 36 participants 105 participants
Female
18
  52.9%
21
  60.0%
20
  55.6%
59
  56.2%
Male
16
  47.1%
14
  40.0%
16
  44.4%
46
  43.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 36 participants 105 participants
Caucasian 31 33 34 98
Non-Caucasian 3 2 2 7
1.Primary Outcome
Title The Aqueous Humor Drug Concentration.
Hide Description An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.
Time Frame Visit 2, 1-14 days following screening visit
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical Analysis of AH Drug Concentration. Modified intent to treat population (mITT). Subjects with non-missing data.
Arm/Group Title Besifloxacin Moxifloxacin Gatifloxacin
Hide Arm/Group Description:
Besifloxacin ophthalmic suspension
Vigamox (moxifloxacin ophthalmic solution, 0.5%)
Zymar (gatifloxacin ophthalmic solution, 0.3%)
Overall Number of Participants Analyzed 32 35 34
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
32 35 34
Mean (Standard Deviation)
Unit of Measure: µg/mL
0.1349  (0.5820) 0.6681  (0.4980) 0.1251  (0.07624)
Time Frame Single ocular administration
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Besifloxacin Moxifloxacin Gatifloxacin
Hide Arm/Group Description Besifloxacin ophthalmic suspension Vigamox (moxifloxacin ophthalmic solution, 0.5%) Zymar (gatifloxacin ophthalmic solution, 0.3%)
All-Cause Mortality
Besifloxacin Moxifloxacin Gatifloxacin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Besifloxacin Moxifloxacin Gatifloxacin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/35 (0.00%)   0/36 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Besifloxacin Moxifloxacin Gatifloxacin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/35 (0.00%)   0/36 (0.00%) 
All drug concentrations were significantly below MIC90 values for relevant staphylococcal species.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s)after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tuyen Ong, MD
Organization: Bausch & Lomb Inc
Phone: (973) 360-6389
EMail: tuyen.ong@bausch.com
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00824070     History of Changes
Other Study ID Numbers: 575
First Submitted: January 15, 2009
First Posted: January 16, 2009
Results First Submitted: September 30, 2010
Results First Posted: October 29, 2010
Last Update Posted: December 13, 2011