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

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cataract

Intervention: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Abayomi Ogundele, PharmD, Study Director, Affiliation: Alcon Research
Mauro Silveira de Queiroz Campos, MD, Principal Investigator, Affiliation: Federal University of São Paulo, Ophthalmology Service

Summary

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

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Mean Aqueous Humor Concentration of Moxifloxacin

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: April 2012
Last updated: June 6, 2013

Page last updated: August 23, 2015

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