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

Study Identifier
GMA-ZYM-08-001
CT.gov Identifier
NCT00874887
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Infections & Vaccines - Other
    • Study Drug
  • moxifloxacin 0.5% HCI ophthalmic solution
  • gatifloxacin ophthalmic solution 0.3%
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    50+ years
    Inclusion and Exclusion 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)

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Minneapolis, Minnesota, United States
    Status
    Not applicable
    Location
    Saskatoon, Saskatchewan, Canada
    Status
    Not applicable