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 (part of Bausch Health Companies Inc.) · 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.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 474 is above the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.
Browse Conjunctivitis, Bacterial studies →Bausch & Lomb Incorporated is the lead sponsor of 223 studies on the registry; 5 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 41 (80%) have results posted.
First submitted before Bausch & Lomb Incorporated became part of Bausch Health Companies Inc..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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Studies of the drug tested here: Besifloxacin