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

Allergan66 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Anti-biotic Resistance

Interventions

moxifloxacin 0.5% HCI ophthalmic solutionDRUG

1 drop in study eye three times a day for 14 days

gatifloxacin ophthalmic solution 0.3%DRUG

1 drop in study eye four times a day for 14 days

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (2)

Unnamed facility

Minneapolis, Minnesota, United States

Unnamed facility

Saskatoon, Saskatchewan, Canada

Outcomes

Primary Outcomes

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.

Time frame: Day 14

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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