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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859702
• Other study ID #: RDG-11-235
• Status: Completed
• Phase: Phase 4
• First received: May 20, 2013
• Last updated: June 6, 2013
• Start date: April 2012
• Est. completion date: August 2012

Study information

• Verified date: June 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Aqueous Humor Concentration of Moxifloxacin	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.	Day 3 (operative day)	No