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

June 6, 2013 updated by: Alcon Research
The purpose of this study was to determine the moxifloxacin aqueous penetration when dosing with a combination drug Vigadexa preoperatively in cataract patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution
Other Names:
  • Vigadexa®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 3 (operative day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Principal Investigator: Mauro Silveira de Queiroz Campos, MD, Federal University of São Paulo, Ophthalmology Service

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

May 20, 2013

First Submitted That Met QC Criteria

May 20, 2013

First Posted (Estimate)

May 22, 2013

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

June 6, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDG-11-235

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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