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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00874887
First received: April 1, 2009
Last updated: November 16, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Anti-biotic Resistance
Drug: moxifloxacin 0.5% HCI ophthalmic solution
Drug: gatifloxacin ophthalmic solution 0.3%
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    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:
  • Mutant Prevention Concentration (MPC) of the Conjunctiva at Day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    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.


Enrollment: 66
Study Start Date: March 2009
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vigamox®
moxifloxacin 0.5% (m mg/mL), boric acid, sodium chloride, and purified water
Drug: moxifloxacin 0.5% HCI ophthalmic solution
1 drop in study eye three times a day for 14 days
Other Name: Vigamox®
Active Comparator: Zymar®
gatifloxacin 0.3% (3 mg/mL), benzalkonium chloride 0.005%, edetate disodium; purified water and sodium chloride
Drug: gatifloxacin ophthalmic solution 0.3%
1 drop in study eye four times a day for 14 days
Other Name: ZYMAR®

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874887

Locations
United States, Minnesota
Minneapolis, Minnesota, United States
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00874887     History of Changes
Other Study ID Numbers: GMA-ZYM-08-001
Study First Received: April 1, 2009
Results First Received: November 16, 2011
Last Updated: November 16, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pharmaceutical Solutions
Moxifloxacin
Gatifloxacin
Fluoroquinolones
Norgestimate, ethinyl estradiol drug combination
Ophthalmic Solutions
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014