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Completed

NCT Number: NCT00874887

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

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.

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Key information

Conditions

Anti-biotic Resistance

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Saskatoon, Saskatchewan, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

moxifloxacin 0.5% HCI ophthalmic solution

Drug

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

Other names: Vigamox®

gatifloxacin ophthalmic solution 0.3%

Drug

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

Other names: ZYMAR®

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: Day 14

    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.

  2. Minimum Inhibitory Concentration 50 (MIC50) at Day 14

    Time frame: Day 14

    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.

  3. Minimum Inhibitory Concentration 90 (MIC90) at Day 14

    Time frame: Day 14

    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.

  4. Minimum Inhibitory Concentration (MIC) Range at Day 14

    Time frame: Day 14

    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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 3, 2009
Registry last updated
Dec 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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