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

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

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

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.