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The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Besivance | Experimental | besifloxacin ophthalmic suspension 0.6% |
|
| Vehicle | Placebo Comparator | Vehicle of Besivance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Besivance | Drug | Ocular administration to affected eye for 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Treatment Emergent Adverse Events | Ocular Treatment-Emergent Adverse Events on the Study Eye | At each visit - 7 days |
| Non-Ocular Treatment-Emergent Adverse Events | Non-Ocular Treatment-Emergent Adverse Events on the Study Eye | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Resolution | The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data | Day 8 (Visit 2) |
| Clinical Resolution |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Allaire, MD | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb, Inc. | Rochester | New York | 14609 | United States |
518 participants with a clinical diagnosis of bacterial conjunctivitis were enrolled in the study, 496 completed the study; 518 participants were in Intent-to-Treat (ITT) population, 514 participants were in Safety population, and 299 participants were in modified Intent-to-Treat (mITT) population (Participants with positive culture at baseline).
First participant entered the study 6/22/2010 and the last participant visit was 12/12/2011. Twenty four sites in the United States participated in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Besivance | besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days |
| FG001 | Vehicle | Vehicle of Besivance Vehicle : Vehicle of Besivance administered to affected eye for 7 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent to treat population (ITT)
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| ID | Title | Description |
|---|---|---|
| BG000 | Besivance | besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days |
| BG001 | Vehicle | Vehicle of Besivance Vehicle : Vehicle of Besivance administered to affected eye for 7 days |
| 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 | Ocular Treatment Emergent Adverse Events | Ocular Treatment-Emergent Adverse Events on the Study Eye | Safety Population | Posted | Number | Events | At each visit - 7 days | eyes | Participants |
|
11 days
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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 | Besivance | besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tuyen Ong, MD, MRCOphth | Bausch & Lomb Inc. | (973) 360-6389 | tuyen.ong@bausch.com |
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| ID | Term |
|---|---|
| D003234 | Conjunctivitis, Bacterial |
| ID | Term |
|---|---|
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C522124 | besifloxacin |
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| Vehicle |
| Drug |
Vehicle of Besivance administered to affected eye for 7 days |
|
The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.
| Day 11 (Visit 3) |
| Microbial Eradication | The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment. | Days 8 (Visit 2) |
| Microbial Eradication | The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment. | Days 11 (Visit 3) |
| Microbial Outcome With Clinical Resolution | At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline | Day 8 (Visit 2) |
| Microbial Outcome With Clinical Resolution | At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline | Day 11 (Visit 3) |
| Individual Clinical Outcomes - Ocular Discharge | ocular conjunctival discharge measured as absent, mild, moderate or severe | At day 1 (Vist 1) |
| Individual Clinical Outcomes - Ocular Discharge | ocular conjunctival discharge measured as absent, mild, moderate or severe | At day 8 (Vist 2) |
| Individual Clinical Outcomes - Ocular Discharge | ocular conjunctival discharge measured as absent, mild, moderate or severe | At day 11 (Vist 3) |
| Individual Clinical Outcomes - Bulbar Injection | Bulbar conjunctival injection measured as normal, mild, moderate or severe | At day 1 (Vist 1) |
| Individual Clinical Outcomes - Bulbar Injection | Bulbar conjunctival injection measured as normal, mild, moderate or severe | At day 8 (Vist 2) |
| Individual Clinical Outcomes - Bulbar Injection | Bulbar conjunctival injection measured as normal, mild, moderate or severe | At day 11 (Vist 3) |
| Adverse Event |
|
| Physician Decision |
|
| Lack of Efficacy |
|
| Residual Bacterial Conjunctivitis |
|
| Treated not as randomized |
|
| Herpes Simplex Dermatitis |
|
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
| eyes |
|
|
| Secondary | Clinical Resolution | The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data | Study eye for the mITT population | Posted | Number | eyes | Day 8 (Visit 2) | eyes | Participants |
|
|
|
| Secondary | Clinical Resolution | The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. | Study eye for the mITT population | Posted | Number | eyes | Day 11 (Visit 3) |
|
|
|
| Secondary | Microbial Eradication | The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment. | Study Eye, Modified Intent-to-Treat Population | Posted | Number | eyes | Days 8 (Visit 2) | eyes | Participants |
|
|
|
| Secondary | Microbial Eradication | The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment. | Study Eye, Modified Intent-to-Treat Population | Posted | Number | eyes | Days 11 (Visit 3) | eyes | Participants |
|
|
|
| Primary | Non-Ocular Treatment-Emergent Adverse Events | Non-Ocular Treatment-Emergent Adverse Events on the Study Eye | Safety Population | Posted | Number | Events | 7 days |
|
|
|
| Secondary | Microbial Outcome With Clinical Resolution | At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline | Modified Intent-to-Treat Population | Posted | Number | eyes | Day 8 (Visit 2) |
|
|
|
| Secondary | Microbial Outcome With Clinical Resolution | At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline | Modified Intent-to-Treat Population | Posted | Number | eyes | Day 11 (Visit 3) | eyes | Participants |
|
|
|
| Secondary | Individual Clinical Outcomes - Ocular Discharge | ocular conjunctival discharge measured as absent, mild, moderate or severe | Baseline-Designated Study Eye (Modified Intent-to- Treat Population) | Posted | Number | eyes | At day 1 (Vist 1) | eyes | Participants |
|
|
|
| Secondary | Individual Clinical Outcomes - Ocular Discharge | ocular conjunctival discharge measured as absent, mild, moderate or severe | Baseline-Designated Study Eye (Modified Intent-to- Treat Population) | Posted | Number | eyes | At day 8 (Vist 2) | eyes | Participants |
|
|
|
| Secondary | Individual Clinical Outcomes - Ocular Discharge | ocular conjunctival discharge measured as absent, mild, moderate or severe | Baseline-Designated Study Eye (Modified Intent-to- Treat Population) | Posted | Number | eyes | At day 11 (Vist 3) | eyes | Participants |
|
|
|
| Secondary | Individual Clinical Outcomes - Bulbar Injection | Bulbar conjunctival injection measured as normal, mild, moderate or severe | Baseline-Designated Study Eye (Modified Intent-to- Treat Population) | Posted | Number | eyes | At day 1 (Vist 1) | eyes | Participants |
|
|
|
| Secondary | Individual Clinical Outcomes - Bulbar Injection | Bulbar conjunctival injection measured as normal, mild, moderate or severe | Baseline-Designated Study Eye (Modified Intent-to- Treat Population) | Posted | Number | eyes | At day 8 (Vist 2) | eyes | Participants |
|
|
|
| Secondary | Individual Clinical Outcomes - Bulbar Injection | Bulbar conjunctival injection measured as normal, mild, moderate or severe | Baseline-Designated Study Eye (Modified Intent-to- Treat Population) | Posted | Number | eyes | At day 11 (Vist 3) | eyes | Participants |
|
|
|
| 0 |
| 347 |
| 0 |
| 347 |
| EG001 | Vehicle | Vehicle of Besivance Vehicle : Vehicle of Besivance administered to affected eye for 7 days | 0 | 171 | 0 | 171 |
The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed. Prior to publication or presentation, a copy of the final text should be forwarded by the Investigator(s) to the Sponsor or its designee, for comment.
| D015817 | Eye Infections |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| Pyrexia |
|
| Nasopharyngitis |
|
| Bronchitis |
|
| Gastroenteritis, Viral |
|
| Otitis Media |
|
| Upper Respiratory Tract Infection |
|
| No Clinical Resolution with Microbial Eradication |
|
| No Clinical Resolution no Microbial Eradication |
|
| No Clinical Resolution with Microbial Eradication |
|
| No Clinical Resolution no Microbial Eradication |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|