Phase 4
Completed N=66
A Clinical Study to Evaluate if Benzalkonium Chloride (BAK) in a Quinolone Eyedrop Reduces the Likelihood of Developing Resistant Organisms
Anti-biotic Resistance
Source: ClinicalTrials.gov NCT00874887 ↗
Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcomePrimary: Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14 — 9.4; 0 Percentage of Subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14 |
9.4; 0 | — |
| SECONDARY Mutant Prevention Concentration (MPC) of the Conjunctiva at Day 14 |
— | — |
| SECONDARY Minimum Inhibitory Concentration 50 (MIC50) at Day 14 |
— | — |
| SECONDARY Minimum Inhibitory Concentration 90 (MIC90) at Day 14 |
— | — |
| SECONDARY Minimum Inhibitory Concentration (MIC) Range at Day 14 |
— | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00874887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.