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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Besifloxacin | Experimental | 0.6% ophthalmic suspension |
|
| Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Besifloxacin | Drug | Besifloxacin 0.6% administered into the study eye two times a day for three days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Resolution | The absence of both conjunctival discharge and bulbar conjunctival injection. | Visit 2 |
| Microbial Eradication | The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline. | Visit 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Resolution | The absence of both conjunctival discharge and bulbar conjunctival injection. | Visit 3 |
| Microbial Eradication | The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael R Paterno, OD | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | Rochester | New York | 14609 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22644963 | Derived | Haas W, Gearinger LS, Hesje CK, Sanfilippo CM, Morris TW. Microbiological etiology and susceptibility of bacterial conjunctivitis isolates from clinical trials with ophthalmic, twice-daily besifloxacin. Adv Ther. 2012 May;29(5):442-55. doi: 10.1007/s12325-012-0023-y. Epub 2012 May 25. | |
| 22420526 | Derived | DeLeon J, Silverstein BE, Allaire C, Gearinger LS, Bateman KM, Morris TW, Comstock TL. Besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis in adults and children. Clin Drug Investig. 2012 May 1;32(5):303-17. doi: 10.2165/11632470-000000000-00000. |
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A total of 474 participants were enrolled in the integrated study in the intent to treat(ITT) population. 276 participants had culture confirmed bacterial conjunctivitis and were assigned to the modified intent to treat(mITT) population. 464 participants were assigned to the safety population. 446 participants completed the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Besifloxacin | 0.6% ophthalmic suspension |
| FG001 | Vehicle | Vehicle of besifloxacin ophthalmic suspension |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Besifloxacin | 0.6% ophthalmic suspension |
| BG001 | Vehicle | Vehicle of besifloxacin ophthalmic suspension |
| 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 | The absence of both conjunctival discharge and bulbar conjunctival injection. | Clinical Resolution at Visit 2, (LOCF), mITT Population. | Posted | Number | eyes | Visit 2 |
|
|
7 days
Safety Population, participants receiving at least one drop of study medication.
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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 | Besifloxacin | 0.6% ophthalmic suspension |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tuyen Ong, MD, MRCOphth | Bausch & Lomb Incorporated | (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 (Placebo) | Drug | Vehicle administered to the study eye two times a day for three days. |
|
| Visit 3 |
| 21397770 | Derived | Silverstein BE, Allaire C, Bateman KM, Gearinger LS, Morris TW, Comstock TL. Efficacy and tolerability of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study in adults and children. Clin Ther. 2011 Jan;33(1):13-26. doi: 10.1016/j.clinthera.2010.12.004. |
| Withdrawal by Subject |
|
| Physician Decision |
|
| Protocol Violation |
|
| Screening Failure |
|
| Missed visit |
|
| BG002 |
| Total |
Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Participants |
|
|
| Primary | Microbial Eradication | The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline. | Microbial Eradication at Visit 2, (LOCF), mITT Population. | Posted | Number | eyes | Visit 2 |
|
|
|
| Secondary | Clinical Resolution | The absence of both conjunctival discharge and bulbar conjunctival injection. | Clinical Resolution at Visit 3, (LOCF) mITT Population. | Posted | Number | eyes | Visit 3 |
|
|
|
| Secondary | Microbial Eradication | The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline. | Microbial Eradication at Visit 3, (LOCF), mITT Population. | Posted | Number | eyes | Visit 3 |
|
|
|
| 0 |
| 228 |
| 0 |
| 228 |
| EG001 | Vehicle | Vehicle of besifloxacin ophthalmic suspension | 0 | 236 | 0 | 236 |
All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. 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.
| D015817 | Eye Infections |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |