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

Anti-biotic Resistance Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874887
• Other study ID #: GMA-ZYM-08-001
• Status: Completed
• Phase: Phase 4
• First received: April 1, 2009
• Last updated: November 16, 2011
• Start date: March 2009
• Est. completion date: October 2009

Study information

• Verified date: November 2011
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Anti-biotic Resistance

Intervention

Drug:
• moxifloxacin 0.5% HCI ophthalmic solution
1 drop in study eye three times a day for 14 days
• gatifloxacin ophthalmic solution 0.3%
1 drop in study eye four times a day for 14 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at 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.	Day 14	No
Secondary	Mutant Prevention Concentration (MPC) of the Conjunctiva at 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.	Day 14	No
Secondary	Minimum Inhibitory Concentration 50 (MIC50) at 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.	Day 14	No
Secondary	Minimum Inhibitory Concentration 90 (MIC90) at 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.	Day 14	No
Secondary	Minimum Inhibitory Concentration (MIC) Range at 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.	Day 14	No