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

Condition(s) targeted: Anti-biotic Resistance

Intervention: moxifloxacin 0.5% HCI ophthalmic solution (Drug); gatifloxacin ophthalmic solution 0.3% (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Primary outcome: Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14

Secondary outcome:

Mutant Prevention Concentration (MPC) of the Conjunctiva at Day 14

Minimum Inhibitory Concentration 50 (MIC50) at Day 14

Minimum Inhibitory Concentration 90 (MIC90) at Day 14

Minimum Inhibitory Concentration (MIC) Range at Day 14

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Minneapolis, Minnesota, United States

Saskatoon, Saskatchewan, Canada

Starting date: March 2009
Last updated: November 16, 2011