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

Allergan

Status and phase: Completed; Phase 4

Conditions: Anti-biotic Resistance

Treatments: Drug: gatifloxacin ophthalmic solution 0.3%; Drug: moxifloxacin 0.5% HCI ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00874887

GMA-ZYM-08-001

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Vigamox®

Active Comparator group

Description:

moxifloxacin 0.5% (m mg/mL), boric acid, sodium chloride, and purified water

Treatment:

Drug: moxifloxacin 0.5% HCI ophthalmic solution

Zymar®

Active Comparator group

Description:

gatifloxacin 0.3% (3 mg/mL), benzalkonium chloride 0.005%, edetate disodium; purified water and sodium chloride

Treatment:

Drug: gatifloxacin ophthalmic solution 0.3%