A Phase 3 interventional study of Besifloxacin and Moxifloxacin solution in Acute Bacterial Conjunctivitis, sponsored by Bausch & Lomb Incorporated. Completed. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2015-03-24.
Sponsored by Bausch & Lomb Incorporated (part of Bausch Health Companies Inc.) · Phase 3, Interventional, and Treatment
This is a study to investigate a novel drug candidate for the treatment of bacterial conjunctivitis.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 1,161 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.
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Exclusion Criteria:
Moxifloxacin hydrochloride ophthalmic solution 0.5%
Drug: Moxifloxacin solution
Besifloxacin hydrochloride ophthalmic suspension 0.6%
Drug: Besifloxacin
Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days
Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days.
Clinical Resolution
Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)
Time frame: Day 5(+/- 1 day)
Microbial Eradication
eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Time frame: Day 5 (+/- 1 day)
Clinical Resolution
Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated
Time frame: Day 8 or Day 9
Microbial Eradication
Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Time frame: Day 8 or Day 9
This study was conducted at 84 sites in the US and Asia. First subject was enrolled 6/6/06, and last subject visit was 7/13/07.
| Milestone | Moxifloxacin Solution | Besifloxacin Suspension |
|---|---|---|
| Started | 579 | 582 |
| Completed | 554 | 555 |
| Not completed | 25 | 27 |
| Withdrew: Adverse event - unrelated to study drug | 0 | 1 |
| Withdrew: Lack of efficacy | 1 | 1 |
| Withdrew: Lost to follow-up | 8 | 10 |
| Withdrew: Withdrawal by subject | 4 | 1 |
| Withdrew: Other | 7 | 4 |
| Withdrew: Dissallowed meds - unrelated to study | 1 | 3 |
| Withdrew: Dissallowed meds - unlikley related | 1 | 1 |
| Withdrew: Dissallowed meds - possibly releated | 1 | 1 |
| Withdrew: Worsening of bc - unrelated to study | 0 | 3 |
| Withdrew: Worsening of bc - unlikely related | 1 | 2 |
| Withdrew: Adverse event probably related to study | 1 | 0 |
Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)
| Participants | Moxifloxacin Solution | Besifloxacin Suspension |
|---|---|---|
| Clinical Resolution | 167 | 147 |
eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
| Participants | Moxifloxacin Solution | Besifloxacin Suspension |
|---|---|---|
| Microbial Eradication | 256 | 235 |
Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated
| Participants | Moxifloxacin Solution | Besifloxacin Suspension |
|---|---|---|
| Clinical Resolution | 236 | 213 |
Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
| Participants | Moxifloxacin Solution | Besifloxacin Suspension |
|---|---|---|
| Microbial Eradication | 238 | 220 |
Collected over Participants were treated three times daily for 5 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Moxifloxacin Solution | — | 1/579 (0.2%) | 0/855 (0%) |
| Besifloxacin Suspension | — | 1/582 (0.2%) | 0/865 (0%) |
| Event | Moxifloxacin Solution | Besifloxacin Suspension |
|---|---|---|
| Acute viral syndromeInfections and infestations | 1/579 | 1/582 |
| Congestive heart failureCardiac disorders | 1/579 | 1/582 |
| Age, Customized(participants) | Moxifloxacin Solution | Besifloxacin Suspension | Total |
|---|---|---|---|
| <2 years | 15 | 22 | 37 |
| 2 to 9 years | 90 | 91 | 181 |
| 10 to 19 years | 81 | 75 | 156 |
| 20 to 29 years | 73 | 93 | 166 |
| 30 to 39 years | 76 | 71 | 147 |
| 40 to 49 years | 59 | 68 | 127 |
| 50 to 59 years | 65 | 63 | 128 |
| >/= 60 years | 120 | 99 | 219 |
| Sex: Female, Male(Participants) | Moxifloxacin Solution | Besifloxacin Suspension | Total |
|---|---|---|---|
| Female | 323 | 332 | 655 |
| Male | 256 | 250 | 506 |
| Race/Ethnicity, Customized(participants) | Moxifloxacin Solution | Besifloxacin Suspension | Total |
|---|---|---|---|
| American Indian or Alaskan Native | 6 | 3 | 9 |
| Asian | 89 | 87 | 176 |
| Black or African American | 63 | 73 | 136 |
| Native Hawaiian or Pacific Islander | 2 | 5 | 7 |
| White | 391 | 385 | 776 |
| Other | 28 | 29 | 57 |
No study locations are listed for this record.
The record gives a start of Jun 2006, a primary completion of Jul 2007 and a completion of Jul 2007. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2009, 2 years 1 month after primary completion.
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This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Besifloxacin