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

NCT00874887 | Completed Phase 4 Results

• 1 other identifier: GMA-ZYM-08-001
• Study Type: interventional
• Target: 66
• Locations: 2 countries
• Sites: 2

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.

Conditions

Anti-biotic Resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  Day 14

• Minimum Inhibitory Concentration 50 (MIC50) at Day 14

  Day 14

• Minimum Inhibitory Concentration 90 (MIC90) at Day 14

  Day 14

• Minimum Inhibitory Concentration (MIC) Range at Day 14

  Day 14

Study Arms (2)

Vigamox®

ACTIVE COMPARATOR

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

Drug: moxifloxacin 0.5% HCI ophthalmic solution

Zymar®

ACTIVE COMPARATOR

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

Drug: gatifloxacin ophthalmic solution 0.3%

Interventions

moxifloxacin 0.5% HCI ophthalmic solution DRUG

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

Also known as: Vigamox®

Vigamox®

gatifloxacin ophthalmic solution 0.3% DRUG

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

Also known as: ZYMAR®

Zymar®

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Saskatoon, Saskatchewan, Canada

Location

MeSH Terms

Interventions

Moxifloxacin; Gatifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Only a small number of resistant species were obtained at the study endpoints. Therefore, some outcome measures were not able to be analyzed.

Results Point of Contact

• Title: Vice President, Medical Affairs
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 3, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 19, 2011
• Results First Posted: December 19, 2011

Record last verified: 2011-11

Locations

US (1); CA (1)