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

NCT ID: NCT01859702

Last Updated: 2013-08-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-08-31

Brief Summary

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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

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Conditions

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Cataract

Keywords

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Aqueous Humor Moxifloxacin Vigadexa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution

Intervention Type DRUG

Interventions

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Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution

Intervention Type DRUG

Other Intervention Names

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Vigadexa®

Eligibility Criteria

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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;

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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abayomi Ogundele, PharmD

Role: STUDY_DIRECTOR

Alcon Research

Mauro Silveira de Queiroz Campos, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo, Ophthalmology Service

Other Identifiers

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RDG-11-235

Identifier Type: -

Identifier Source: org_study_id