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

NCT01859702 | Completed Phase 4 Results

• 1 other identifier: RDG-11-235
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract

Keywords

Aqueous Humor; Moxifloxacin; Vigadexa

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

VIGADEXA

EXPERIMENTAL

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.

Drug: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution

Interventions

Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution DRUG

Also known as: Vigadexa®

VIGADEXA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Requires cataract surgery;
• Acceptable health status (medical history, physical, laboratory and ophthalmologic exams);
• Able to follow instructions and willing to attend all study visits;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Cataract

Interventions

Moxifloxacin; Dexamethasone; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Abayomi Ogundele, Global Medical Affairs Brand Lead
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Abayomi Ogundele, PharmD

  Alcon Research

  STUDY DIRECTOR

• Mauro Silveira de Queiroz Campos, MD

  Federal University of São Paulo, Ophthalmology Service

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 22, 2013
• Study Start: April 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 7, 2013
• Results First Posted: August 7, 2013

Record last verified: 2013-06