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This is a study to investigate a novel drug candidate for the treatment of bacterial conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxifloxacin solution | Active Comparator | Moxifloxacin hydrochloride ophthalmic solution 0.5% |
|
| Besifloxacin Suspension | Experimental | Besifloxacin hydrochloride ophthalmic suspension 0.6% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Besifloxacin | Drug | Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Resolution | Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated) | Day 5(+/- 1 day) |
| Microbial Eradication | eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated | Day 5 (+/- 1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Resolution | Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated | Day 8 or Day 9 |
| Microbial Eradication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Comstock, OD | Bausch & Lomb Incorporated | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32841261 | Derived | DeCory HH, Sanfilippo CM, Proskin HM, Blondeau JM. Characterization of baseline polybacterial versus monobacterial infections in three randomized controlled bacterial conjunctivitis trials and microbial outcomes with besifloxacin ophthalmic suspension 0.6. PLoS One. 2020 Aug 25;15(8):e0237603. doi: 10.1371/journal.pone.0237603. eCollection 2020. | |
| 20629472 |
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1161 participants were randomized of which 533 had culture confirmed bacterial conjunctivitis.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Moxifloxacin Solution | Moxifloxacin hydrochloride ophthalmic solution 0.5% |
| FG001 | Besifloxacin Suspension | Besifloxacin ophthalmic suspension 0.6% |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Moxifloxacin Solution | Moxifloxacin hydrochloride ophthalmic solution 0.5% |
| BG001 | Besifloxacin Suspension | Besifloxacin ophthalmic suspension 0.6% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Resolution | Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated) | modified intent to treat (mITT), culture confirmed, as treated | Posted | Number | Participants | Day 5(+/- 1 day) |
|
Participants were treated three times daily for 5 days
Safety population - All treated eyes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moxifloxacin Solution | Moxifloxacin hydrochloride ophthalmic solution 0.5% |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute viral syndrome | Infections and infestations | MedDRA (10.0) | Systematic Assessment | Unlikely related to treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy Comstock | Bausch & Lomb Incorporated | (585) 338-6631 | timothy.comstock@bausch.com |
| ID | Term |
|---|---|
| C522124 | besifloxacin |
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| Moxifloxacin solution | Drug | Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days. |
|
Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
| Day 8 or Day 9 |
| Comstock TL, Paterno MR, Decory HH, Usner DW. Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis: data from six clinical and phase I safety studies. Clin Drug Investig. 2010;30(10):675-85. doi: 10.2165/11536720-000000000-00000. |
| Lost to Follow-up |
|
| Withdrawal by Subject |
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| Other |
|
| Dissallowed Meds - unrelated to study |
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| Dissallowed Meds - unlikley related |
|
| Dissallowed Meds - possibly releated |
|
| Worsening of BC - Unrelated to study |
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| Worsening of BC - Unlikely related |
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| Adverse event probably related to study |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Microbial Eradication | eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated | modified intent to treat (mITT), culture confirmed, as treated | Posted | Number | Participants | Day 5 (+/- 1 day) |
|
|
|
| Secondary | Clinical Resolution | Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated | modified intent to treat (mITT), culture confirmed, as treated | Posted | Number | Participants | Day 8 or Day 9 |
|
|
|
| Secondary | Microbial Eradication | Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated | modified intent to treat (mITT), culture confirmed, as treated | Posted | Number | Participants | Day 8 or Day 9 |
|
|
|
| 1 |
| 579 |
| 0 |
| 855 |
| EG001 | Besifloxacin Suspension | Besifloxacin ophthalmic suspension 0.6% | 1 | 582 | 0 | 865 |
|
| Congestive heart failure | Cardiac disorders | MedDRA (10.0) | Systematic Assessment | Considered unrelated to therapy |
|
Sponsor has 45 days to review materials and provide comments back to the investigator.