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Trial record 14 of 19 for:    "Lens Disease" | "Estradiol"

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

Tracking Information
First Submitted Date  ICMJE May 20, 2013
First Posted Date  ICMJE May 22, 2013
Results First Submitted Date  ICMJE June 6, 2013
Results First Posted Date  ICMJE August 7, 2013
Last Update Posted Date August 7, 2013
Study Start Date  ICMJE April 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2013)
Mean Aqueous Humor Concentration of Moxifloxacin [ Time Frame: Day 3 (operative day) ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01859702 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients
Official Title  ICMJE Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients
Brief Summary The purpose of this study was to determine the moxifloxacin aqueous penetration when dosing with a combination drug Vigadexa preoperatively in cataract patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Cataract
Intervention  ICMJE Drug: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution
Other Name: Vigadexa®
Study Arms  ICMJE Experimental: VIGADEXA
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.
Intervention: Drug: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2013)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Requires cataract surgery;
  • Acceptable health status (medical history, physical, laboratory and ophthalmologic exams);
  • Able to follow instructions and willing to attend all study visits;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any known or suspected allergies/hypersensitivity to any of the investigational test product components;
  • History of invasive intraocular surgery in the eye to be operated, within 4 months before enrollment;
  • Use of medications, as specified in protocol;
  • Severe dry eye syndrome;
  • Use of contact lenses two days before surgery until the last visit;
  • External eye disease, infection or inflammation of the eyes or eyelids;
  • Excessive bleeding tendency;
  • No vision in the eye not included in the study;
  • Pregnant or breastfeeding;
  • Other protocol-defined exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01859702
Other Study ID Numbers  ICMJE RDG-11-235
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Abayomi Ogundele, PharmD Alcon Research
Principal Investigator: Mauro Silveira de Queiroz Campos, MD Federal University of São Paulo, Ophthalmology Service
PRS Account Alcon Research
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP