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

Phase 4

Completed

• Conditions: Cataract
• Interventions: Drug: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution

• Registration Number: NCT01859702
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2013-05-20
• Study First Submitted QC: 2013-05-20
• Study First Posted: 2013-05-22
• Status Verified: 2013-06
• Results First Submitted: 2013-06-06
• Results First Submitted QC: 2013-06-06
• Last Update Submitted: 2013-06-06
• Results First Posted: 2013-08-07
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VIGADEXA	Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution	Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.

Primary Outcome Measures

Name	Time	Method
Mean Aqueous Humor Concentration of Moxifloxacin	Day 3 (operative day)	A 0.150 milliliter sample of the aqueous humor was obtained during cataract surgery. The concentration of moxifloxacin was measured by a validated procedure using high performance liquid-spectrometry.