Overview
Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients
Status:
Completed
Completed
Trial end date:
2012-08-01
2012-08-01
Target enrollment:
0
0
Participant gender:
All
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 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Alcon ResearchTreatments:
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.