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Trial record 9 of 507 for:    MOXIFLOXACIN

Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients

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ClinicalTrials.gov Identifier: NCT01859702
Recruitment Status : Completed
First Posted : May 22, 2013
Results First Posted : August 7, 2013
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Cataract
Intervention Drug: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution
Enrollment 36
Recruitment Details Subjects were recruited from one study center in Brazil.
Pre-assignment Details This reporting group includes all enrolled subjects.
Arm/Group Title VIGADEXA
Hide Arm/Group Description Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
Period Title: Overall Study
Started 36
Completed 31
Not Completed 5
Reason Not Completed
Protocol deviation             3
Adverse Event             2
Arm/Group Title VIGADEXA
Hide Arm/Group Description Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
This reporting group includes all enrolled subjects who received all doses of the test product.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants
71.2  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
21
  60.0%
Male
14
  40.0%
1.Primary Outcome
Title Mean Aqueous Humor Concentration of Moxifloxacin
Hide Description A 0.150 milliliter sample of the aqueous humor was obtained during cataract surgery. The concentration of moxifloxacin was measured by a validated procedure using high performance liquid-spectrometry.
Time Frame Day 3 (operative day)
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol: All subjects who met inclusion/exclusion criteria, received all doses of the test product, and underwent cataract surgery with aqueous humor sampling.
Arm/Group Title VIGADEXA
Hide Arm/Group Description:
Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
Overall Number of Participants Analyzed 31
Mean (95% Confidence Interval)
Unit of Measure: nanograms per milliliter
1110.6
(857.5 to 1363.7)
Time Frame Adverse events were collected for the duration of the study. An adverse event was defined as any untoward medical occurrence, or deterioration of a pre-existing medical condition, that occurred during or after test product administration.
Adverse Event Reporting Description Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
 
Arm/Group Title VIGADEXA
Hide Arm/Group Description Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
All-Cause Mortality
VIGADEXA
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
VIGADEXA
Affected / at Risk (%)
Total   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%
VIGADEXA
Affected / at Risk (%)
Total   2/36 (5.56%) 
Cardiac disorders   
Hypertensive Crisis   2/36 (5.56%) 
Indicates events were collected by systematic assessment
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.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Abayomi Ogundele, Global Medical Affairs Brand Lead
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01859702     History of Changes
Other Study ID Numbers: RDG-11-235
First Submitted: May 20, 2013
First Posted: May 22, 2013
Results First Submitted: June 6, 2013
Results First Posted: August 7, 2013
Last Update Posted: August 7, 2013