Phase 4
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
Bottom Line
View on ClinicalTrials.gov: NCT00874887 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- moxifloxacin 0.5% HCI ophthalmic solution (Drug); gatifloxacin ophthalmic solution 0.3% (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Sep 2009
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 |
— | — |
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.
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.