Trial · NCT00874887
A Clinical Study to Evaluate if Benzalkonium Chloride (BAK) in a Quinolone Eyedrop Reduces the Likelihood of Developing Resistant Organisms
NCT00874887, Phase 4, Completed, Allergan; results first posted 2011-12-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Study to Evaluate if Benzalkonium Chloride (BAK) in a Quinolone Eyedrop Reduces the Likelihood of Developing Resistant Organisms. Trials, record NCT00874887. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00874887
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study to Evaluate if Benzalkonium Chloride (BAK) in a Quinolone Eyedrop Reduces the Likelihood of Developing Resistant Organisms
- NCT number
- NCT00874887
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 66 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Anti-biotic Resistance
- Interventions
- moxifloxacin 0.5% HCI ophthalmic solution, gatifloxacin ophthalmic solution 0.3%
- First posted
- 2009-04-03
- Last updated
- 2011-12-19
- Results first posted
- 2011-12-19
- Limitations and caveats
- Only a small number of resistant species were obtained at the study endpoints. Therefore, some outcome measures were not able to be analyzed.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14 | 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 | Mutant Prevention Concentration (MPC) of the Conjunctiva at Day 14 | 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. |
| Secondary | Minimum Inhibitory Concentration 50 (MIC50) at Day 14 | 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. |
| Secondary | Minimum Inhibitory Concentration 90 (MIC90) at Day 14 | 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. |
| Secondary | Minimum Inhibitory Concentration (MIC) Range at Day 14 | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14 | Day 14 | The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. One patient in the Zymar® group did not have cultures performed at Day 14. | Percentage of Subjects | NUMBER |
| SECONDARY | Mutant Prevention Concentration (MPC) of the Conjunctiva at Day 14 | Day 14 | The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points. | micrograms per milliliter (ug/mL) | NUMBER |
| SECONDARY | Minimum Inhibitory Concentration 50 (MIC50) at Day 14 | Day 14 | The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points. | micrograms per milliliter (ug/mL) | NUMBER |
| SECONDARY | Minimum Inhibitory Concentration 90 (MIC90) at Day 14 | Day 14 | The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points. | micrograms per milliliter (ug/mL) | NUMBER |
| SECONDARY | Minimum Inhibitory Concentration (MIC) Range at Day 14 | Day 14 | The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points. | micrograms per milliliter (ug/mL) | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14 | Vigamox® | 9.4 | Percentage of Subjects | ||
| Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14 | Zymar® | 0 | Percentage of Subjects |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vigamox® | 32 | |
| Overall Study | STARTED | Zymar® | 34 | |
| Overall Study | COMPLETED | Vigamox® | 32 | |
| Overall Study | COMPLETED | Zymar® | 34 | |
| Overall Study | NOT COMPLETED | Vigamox® | 0 | |
| Overall Study | NOT COMPLETED | Zymar® | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vigamox® | ||
| Total, all-cause mortality | Zymar® | ||
| Total, other adverse events | Vigamox® | 0 | 32 |
| Total, other adverse events | Zymar® | 0 | 34 |
| Total, serious adverse events | Vigamox® | 0 | 32 |
| Total, serious adverse events | Zymar® | 0 | 34 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Vigamox® vs Zymar®: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00874887
GET https://conductscience.org/api/trials/v1/NCT00874887/registered