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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Anti-Bacterial Agents; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ophthalmic Solutions

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.