A Phase 2/3 interventional study of Besifloxacin and Vehicle (Placebo) in Bacterial Conjunctivitis, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2012-03-29.
Sponsored by Bausch & Lomb Incorporated · Phase 2/3, Interventional, and Treatment
This study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis. This study was conducted as a phase IIb study and continued with further enrollment as a phase III study.
Exclusion Criteria:
0.6% ophthalmic suspension
Drug: Besifloxacin
Drug: Vehicle (Placebo)
Besifloxacin 0.6% administered into the study eye two times a day for three days.
Also known as: Besivance
Vehicle administered to the study eye two times a day for three days.
Clinical Resolution
The absence of both conjunctival discharge and bulbar conjunctival injection.
Time frame: Visit 2
Microbial Eradication
The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.
Time frame: Visit 2
Clinical Resolution
The absence of both conjunctival discharge and bulbar conjunctival injection.
Time frame: Visit 3
Microbial Eradication
The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.
Time frame: Visit 3
This was a two phase (IIB/III) integrated study. Phase IIb was conducted at 31 sites and Phase III at 28 sites in the United States. The first participant was enrolled in phase IIb on 10/30/2009, and last participant exited the study on 04/09/2010. Phase III enrolled its first participant on 04/05/2010 and last participant exited on 10/13/2010.
| Milestone | Besifloxacin | Vehicle |
|---|---|---|
| Started | 231 | 243 |
| Completed | 217 | 229 |
| Not completed | 14 | 14 |
| Withdrew: Adverse event | 3 | 2 |
| Withdrew: Lost to follow-up | 0 | 4 |
| Withdrew: Withdrawal by subject | 4 | 5 |
| Withdrew: Physician decision | 4 | 0 |
| Withdrew: Protocol violation | 0 | 2 |
| Withdrew: Screening failure | 2 | 1 |
| Withdrew: Missed visit | 1 | 0 |
The absence of both conjunctival discharge and bulbar conjunctival injection.
| eyes | Besifloxacin | Vehicle |
|---|---|---|
| Clinical Resolution | 89 | 62 |
The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.
| eyes | Besifloxacin | Vehicle |
|---|---|---|
| Microbial Eradication | 115 | 77 |
The absence of both conjunctival discharge and bulbar conjunctival injection.
| eyes | Besifloxacin | Vehicle |
|---|---|---|
| Clinical Resolution | 103 | 94 |
The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.
| eyes | Besifloxacin | Vehicle |
|---|---|---|
| Microbial Eradication | 115 | 91 |
Collected over 7 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Besifloxacin | — | 0/228 (0%) | 0/228 (0%) |
| Vehicle | — | 0/236 (0%) | 0/236 (0%) |
| Age, Customized(participants) | Besifloxacin | Vehicle | Total |
|---|---|---|---|
| <2 years | 14 | 13 | 27 |
| 2 - 11 years | 66 | 77 | 143 |
| 12 - 17 years | 19 | 20 | 39 |
| 18 - 29 years | 32 | 40 | 72 |
| 30 - 39 years | 21 | 29 | 50 |
| 40 - 49 years | 23 | 14 | 37 |
| 50 - 59 years | 20 | 19 | 39 |
| >=60 years | 35 | 31 | 66 |
| Missing | 1 | 0 | 1 |
| Sex: Female, Male(Participants) | Besifloxacin | Vehicle | Total |
|---|---|---|---|
| Female | 142 | 133 | 275 |
| Male | 89 | 110 | 199 |
| Race/Ethnicity, Customized(participants) | Besifloxacin | Vehicle | Total |
|---|---|---|---|
| American Indian or Alaska Native | 7 | 5 | 12 |
| Asian | 7 | 7 | 14 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 2 |
| Black or African American | 45 | 58 | 103 |
| White | 167 | 166 | 333 |
| Other | 4 | 5 | 9 |
| Missing | 1 | 0 | 1 |
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bausch & Lomb Incorporated