Trial · NCT00348348
A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis
NCT00348348, Phase 3, Completed, Bausch & Lomb Incorporated; results first posted 2009-08-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis. Trials, record NCT00348348. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00348348
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis
- NCT number
- NCT00348348
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,161 participants, actual
- Lead sponsor
- Bausch & Lomb Incorporated
- Conditions
- Acute Bacterial Conjunctivitis
- Interventions
- Besifloxacin, Moxifloxacin solution
- First posted
- 2006-07-04
- Last updated
- 2015-03-24
- Results first posted
- 2009-08-13
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Resolution | Day 5(+/- 1 day) | Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated) |
| Primary | Microbial Eradication | Day 5 (+/- 1 day) | eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated |
| Secondary | Clinical Resolution | Day 8 or Day 9 | Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated |
| Secondary | Microbial Eradication | Day 8 or Day 9 | Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Resolution | Day 5(+/- 1 day) | modified intent to treat (mITT), culture confirmed, as treated | Participants | NUMBER |
| PRIMARY | Microbial Eradication | Day 5 (+/- 1 day) | modified intent to treat (mITT), culture confirmed, as treated | Participants | NUMBER |
| SECONDARY | Clinical Resolution | Day 8 or Day 9 | modified intent to treat (mITT), culture confirmed, as treated | Participants | NUMBER |
| SECONDARY | Microbial Eradication | Day 8 or Day 9 | modified intent to treat (mITT), culture confirmed, as treated | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Resolution | Moxifloxacin Solution | 167 | Participants | ||
| Clinical Resolution | Besifloxacin Suspension | 147 | Participants | ||
| Microbial Eradication | Moxifloxacin Solution | 256 | Participants | ||
| Microbial Eradication | Besifloxacin Suspension | 235 | Participants | ||
| Clinical Resolution | Moxifloxacin Solution | 236 | Participants | ||
| Clinical Resolution | Besifloxacin Suspension | 213 | Participants | ||
| Microbial Eradication | Moxifloxacin Solution | 238 | Participants | ||
| Microbial Eradication | Besifloxacin Suspension | 220 | Participants |
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 | Moxifloxacin Solution | 579 | |
| Overall Study | STARTED | Besifloxacin Suspension | 582 | |
| Overall Study | COMPLETED | Moxifloxacin Solution | 554 | |
| Overall Study | COMPLETED | Besifloxacin Suspension | 555 | |
| Overall Study | NOT COMPLETED | Moxifloxacin Solution | 25 | |
| Overall Study | NOT COMPLETED | Besifloxacin Suspension | 27 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Acute viral syndrome | Infections and infestations | Moxifloxacin Solution | 1 | 579 | 1 |
| serious | Acute viral syndrome | Infections and infestations | Besifloxacin Suspension | 1 | 582 | 1 |
| serious | Congestive heart failure | Cardiac disorders | Moxifloxacin Solution | 1 | 579 | 1 |
| serious | Congestive heart failure | Cardiac disorders | Besifloxacin Suspension | 1 | 582 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Moxifloxacin Solution | ||
| Total, all-cause mortality | Besifloxacin Suspension | ||
| Total, other adverse events | Moxifloxacin Solution | 0 | 855 |
| Total, other adverse events | Besifloxacin Suspension | 0 | 865 |
| Total, serious adverse events | Moxifloxacin Solution | 1 | 579 |
| Total, serious adverse events | Besifloxacin Suspension | 1 | 582 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Moxifloxacin Solution vs Besifloxacin Suspension: Clinical Resolution | Trial comparisons |
| Moxifloxacin Solution vs Besifloxacin Suspension: Microbial Eradication | Trial comparisons |
| Moxifloxacin Solution vs Besifloxacin Suspension: Clinical Resolution | Trial comparisons |
| Moxifloxacin Solution vs Besifloxacin Suspension: Microbial Eradication | Trial comparisons |
| Moxifloxacin Solution vs Besifloxacin Suspension: serious adverse events | 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/NCT00348348
GET https://conductscience.org/api/trials/v1/NCT00348348/registered