Status:
COMPLETED
Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients
Lead Sponsor:
Alcon Research
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study was to determine the moxifloxacin aqueous penetration when dosing with a combination drug Vigadexa preoperatively in cataract patients.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01859702
Start Date
April 1 2012
End Date
August 1 2012
Last Update
August 7 2013
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