A Clinical Study to Evaluate if Benzalkonium Chloride (BAK) in a Quinolone Eyedrop Reduces the Likelihood of Developing Resistant Organisms

The purpose of this study is to assess if the presence of BAK in a fluoroquinolone in the study eye affects the development of resistant bacteria on the conjunctiva based upon changes in the surface flora over the course of 2 weeks of topical treatment in healthy adult subjects.

Study Overview

• Status: Completed
• Conditions: Anti-biotic Resistance
• Intervention / Treatment: Drug: moxifloxacin 0.5% HCI ophthalmic solution; Drug: gatifloxacin ophthalmic solution 0.3%

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada
• United States
  • Minnesota
    • Minneapolis, Minnesota, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or Female
• At least 50 years of age
• In good general health

Exclusion Criteria:

• Any ocular surgery or use of topical antibiotics or antiseptics in either eye within the last 3 months
• Use of topical steroids, or non-steroidal anti inflammatory drugs in either eye within 30 days of Baseline (or anticipated during the study)
• Use of lid scrubs within 7 days of Baseline in either eye (or anticipated use during the study)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vigamox®; moxifloxacin 0.5% (m mg/mL), boric acid, sodium chloride, and purified water	Drug: moxifloxacin 0.5% HCI ophthalmic solution; 1 drop in study eye three times a day for 14 days; Other Names: Vigamox®
Active Comparator: Zymar®; gatifloxacin 0.3% (3 mg/mL), benzalkonium chloride 0.005%, edetate disodium; purified water and sodium chloride	Drug: gatifloxacin ophthalmic solution 0.3%; 1 drop in study eye four times a day for 14 days; Other Names: ZYMAR®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14	Percentage of subjects with strain resistance as determined by Minimum Inhibitory Concentration (MIC) of the conjunctiva (clear membrane covering the white surface of the eye) at day 14. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The MIC cut-off values include: Intermediate is 1 to less than 2; Resistant is greater than or equal to 2.	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mutant Prevention Concentration (MPC) of the Conjunctiva at Day 14	Mutant Prevention Concentration (MPC) of the conjunctiva (clear membrane covering the white surface of the eye) at day 14. MPC is the lowest drug concentration which prevents growth of any colony of bacteria on the conjunctiva. The MPC outcome measure was not analyzed due to the low number of data points.	Day 14
Minimum Inhibitory Concentration 50 (MIC50) at Day 14	The Minimum Inhibitory Concentration 50 (MIC50) is the minimum concentration required to inhibit the growth of 50% of microorganisms. The MIC50 outcome measure was not analyzed due to the low number of data points.	Day 14
Minimum Inhibitory Concentration 90 (MIC90) at Day 14	The Minimum Inhibitory Concentration 90 (MIC90) is the minimum concentration required to inhibit the growth of 90% of microorganisms. The MIC90 outcome measure was not analyzed due to the low number of data points.	Day 14
Minimum Inhibitory Concentration (MIC) Range at Day 14	MIC range at day 14. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The MIC cut-off values include: Intermediate is 1 to less than 2; Resistant is greater than or equal to 2. The MIC outcome measure was not analyzed due to the low number of data points.	Day 14

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: April 1, 2009
• First Submitted That Met QC Criteria: April 2, 2009
• First Posted (Estimate): April 3, 2009

Study Record Updates

• Last Update Posted (Estimate): December 19, 2011
• Last Update Submitted That Met QC Criteria: November 16, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin; Ophthalmic Solutions; Pharmaceutical Solutions; Gatifloxacin
• Other Study ID Numbers: GMA-ZYM-08-001