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Lack of enrollment
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The objective of this study is to evaluate the safety and efficacy of Besivance (besifloxacin 0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution when administered three times daily (TID) for seven days to neonatal subjects who are 31 days or younger on the day of randomization (Visit 1).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Besivance | Experimental | Besifloxacin 0.6% ophthalmic suspension |
|
| Gatifloxacin | Active Comparator | Gatifloxacin 0.3% ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Besivance | Drug | Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Resolution | Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia. | Visit 5 (Day 8+1) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Resolution | Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia. | Visit 3 (Day 3) |
| Microbial Eradication | Eradication defined as the absence of all accepted ocular bacterial species (as measured on the ordinal scale) that were present at or above threshold at baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson Varughese | Valeant/Bausch & Lomb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | Bridgewater | New Jersey | 08807 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Besivance | Besifloxacin 0.6% ophthalmic suspension Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days |
| FG001 | Gatifloxacin | Gatifloxacin 0.3% ophthalmic solution Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Besivance | Besifloxacin 0.6% ophthalmic suspension Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days |
| BG001 | Gatifloxacin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia. | The analysis population only includes those for whom the outcome was measured within the specified time frame. | Posted | Number | participants | Visit 5 (Day 8+1) |
|
The period of observation for collection of AEs extended from the time the subject's parent/legally authorized representative provided informed consent until the last study visit, Visit 5.
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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 0.6% ophthalmic suspension Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis Bacterial | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johnson Varughese | Valeant Pharmaceuticals | 908-541-2179 | Johnson.Varughese@valeant.com |
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| ID | Term |
|---|---|
| D003234 | Conjunctivitis, Bacterial |
| D015818 | Eye Infections, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015817 | Eye Infections |
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| ID | Term |
|---|---|
| C522124 | besifloxacin |
| D000077734 | Gatifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Gatifloxacin | Drug | Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days |
|
| Visit 5 (Day 8+1) |
| Microbial Outcome | Microbial outcome for the following groups of accepted ocular bacterial species that were present at or above threshold at baseline:
| Visit 3 (Day 3) and Visit 5 (Day 8+1) |
Gatifloxacin 0.3% ophthalmic solution
Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days
| BG002 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Clinical Resolution | Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia. | The analysis population only includes those for whom the outcome was measured within the specified time frame. | Posted | Number | participants | Visit 3 (Day 3) |
|
|
|
| Secondary | Microbial Eradication | Eradication defined as the absence of all accepted ocular bacterial species (as measured on the ordinal scale) that were present at or above threshold at baseline | The analysis population only includes those for whom the outcome was measured within the specified time frame. | Posted | Number | participants | Visit 5 (Day 8+1) |
|
|
|
| Secondary | Microbial Outcome | Microbial outcome for the following groups of accepted ocular bacterial species that were present at or above threshold at baseline:
| The analysis population only includes those for whom the outcome was measured within the specified time frame. A subject may have tested positive for multiple bacterial species (up to 5 species). | Posted | Number | events | Visit 3 (Day 3) and Visit 5 (Day 8+1) |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Gatifloxacin | Gatifloxacin 0.3% ophthalmic solution Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days | 0 | 17 | 5 | 17 |
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Irritability | Psychiatric disorders | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acne Infantile | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
For a period of ten years, the PI agrees to keep confidential and not disclose, without the prior written consent of Sponsor, to any third party or use any technology, data, reports, results of clinical studies conducted under this Study or other information received by Sponsor, or any technology, data, reports, study materials, or other information developed by Sponsor unless disclosure by PI is required by law.
| D003231 |
| Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Visit 5 (Day 8) Gram-Positive |
|
| Visit 5 (Day8) Gram-Negative |
|