Phase 4
Completed N=36
Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients
Source: ClinicalTrials.gov NCT01859702 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Mean Aqueous Humor Concentration of Moxifloxacin — 1110.6 nanograms per milliliter
Summary
The purpose of this study was to determine the moxifloxacin aqueous penetration when dosing with a combination drug Vigadexa preoperatively in cataract patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Aqueous Humor Concentration of Moxifloxacin |
1110.6 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01859702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.