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
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