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

Phase 4

Completed

• Conditions: Anti-biotic Resistance
• Interventions: Drug: moxifloxacin 0.5% HCI ophthalmic solution; Drug: gatifloxacin ophthalmic solution 0.3%

• Registration Number: NCT00874887
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-01
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Primary Completion: 2009-09
• Study Completion: 2009-10
• Status Verified: 2011-11
• Results First Submitted: 2011-11-16
• Results First Submitted QC: 2011-11-16
• Last Update Submitted: 2011-11-16
• Results First Posted: 2011-12-19
• Last Update Posted: 2011-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vigamox®	moxifloxacin 0.5% HCI ophthalmic solution	moxifloxacin 0.5% (m mg/mL), boric acid, sodium chloride, and purified water
Zymar®	gatifloxacin ophthalmic solution 0.3%	gatifloxacin 0.3% (3 mg/mL), benzalkonium chloride 0.005%, edetate disodium; purified water and sodium chloride

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14	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.

Secondary Outcome Measures

Name	Time	Method
Mutant Prevention Concentration (MPC) of the Conjunctiva at Day 14	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.
Minimum Inhibitory Concentration 50 (MIC50) at Day 14	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.
Minimum Inhibitory Concentration 90 (MIC90) at Day 14	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.
Minimum Inhibitory Concentration (MIC) Range at Day 14	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.