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

Overview

The purpose of this study was to determine the moxifloxacin aqueous penetration when dosing with a combination drug Vigadexa preoperatively in cataract patients.

Full Title of Study: “Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2012

Interventions

  • Drug: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alcon Research
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Abayomi Ogundele, PharmD, Study Director, Alcon Research
    • Mauro Silveira de Queiroz Campos, MD, Principal Investigator, Federal University of São Paulo, Ophthalmology Service

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