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| Name | Class |
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| Bausch & Lomb Incorporated | INDUSTRY |
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The goal of the study is to evaluate the application of Besivance™ (besifloxacin ophthalmic suspension, 0.6%) to treat congenital nasolacrimal duct obstruction in children. The hypothesis of the study is that Besivance™ is as safe and effective as the current standard of care for the treatment of nasolacrimal duct obstruction in children.
The primary objective of this study is to evaluate the safety and efficacy of Besivance™ as an antibiotic treatment for congenital nasolacrimal duct obstruction with infection in children. The primary outcome measure is the change from baseline on the physician rated scale of Nasolacrimal Duct Obstruction (NLDO)with infection to follow-up visit #2 (Week 8) or at the time of treatment failure, if earlier.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Besivance Treatment Group | Experimental | Besivance™ ophthalmic suspension, 0.6% |
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| Polytrim Treatment Group | Active Comparator | Polytrim ophthalmic solution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Besivance Treatment Group | Drug | Subjects Receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Physician-rated Scale of NLDO From Baseline to Follow-Up Visit at Week 8 or From Baseline to Time of Treatment Failure, if Earlier. | The NLDO grading scale in the study eye at every visit. The scale ranges from 0 to +4:
Due to varying baseline severity (measured by NLDO grade) among subjects, change from baseline to week 8 in NLDO grade was further classified as the following: Treatment success: grade of 0 or improvement by 2 or more compared to the prior visit. Recurrence: NLDO with infection returns in the study eye, as indicated by a NLDO grade >0 after a grade of 0 at the prior visit. Treatment Failure: grade is worse than or same as the baseline visit. | Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Recurrences by Randomization Group | Recurrence is defined as when the NLDO with infection in the subject's study eye returns, as indicated by a NLDO grading scale of greater than zero after achieving a grade of zero at the previous visit. Number of subjects who had a recurrence event of the subjects who completed the study by treatment Group. | Baseline to Week 16 (Closeout Visit ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suqin Guo, M.D. | Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School | Newark | New Jersey | 07103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Besivance Treatment Group | Subjects receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily for 10 days. |
| FG001 | Polytrim Treatment Group | Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily for 10 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Polytrim Treatment Group | Drug | Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days. |
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| Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO | Subjects who experience recurrence were re-treated as if they were a new patient, with the same study medication, were followed up then classified as "Treatment Success" or "Treatment Failure" according to study protocol. | Baseline to Week 16 (Closeout Visit) |
| Treatment Failure | Possible treatment failure at a follow-up examination is operationally defined as follows: if the physician-grading scale of NLDO is worse than or same as the prior visit at any given follow-up visit, possible treatment failure then exists. Treatment Failure occurred if at visit #1 (2-week visit), the physician-grading scale of NLDO is worse than or same as the baseline visit. Treatment failure can also occur at recurrence visit #1 if the NLDO grading scale is worse or the same as compared to the previous visit. Subjects who meet the criteria for treatment failure were withdrawn from the study by the principal investigator and no additional data was collected. Subjects were referred for continued care. | Baseline to the time of failure or Week 16 (Closeout Visit) |
| Medication Safety Outcomes | During each study visit, the Principal Investigator will evaluate any possible adverse events by assessing clinical complaints and symptoms that are experienced by subjects and observed by the parent(s)/legal guardian(s), including findings in external, lacrimal duct system and anterior segment using slit lamp and fundus exam using indirect ophthalmoscope by principal investigator, as well as clinical signs including findings in external, nasolacrimal duct system and anterior segment using slit lamp and fundus exam using indirect ophthalmoscope by principal investigator. | Baseline to Week 16 (Closeout Visit ) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Besivance Treatment Group | Subjects received Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days. |
| BG001 | Polytrim Treatment Group | Subjects received Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | days |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||
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| Primary | Change in Physician-rated Scale of NLDO From Baseline to Follow-Up Visit at Week 8 or From Baseline to Time of Treatment Failure, if Earlier. | The NLDO grading scale in the study eye at every visit. The scale ranges from 0 to +4:
Due to varying baseline severity (measured by NLDO grade) among subjects, change from baseline to week 8 in NLDO grade was further classified as the following: Treatment success: grade of 0 or improvement by 2 or more compared to the prior visit. Recurrence: NLDO with infection returns in the study eye, as indicated by a NLDO grade >0 after a grade of 0 at the prior visit. Treatment Failure: grade is worse than or same as the baseline visit. | Posted | Number | participants | Baseline to Week 8 |
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| Secondary | Number of Recurrences by Randomization Group | Recurrence is defined as when the NLDO with infection in the subject's study eye returns, as indicated by a NLDO grading scale of greater than zero after achieving a grade of zero at the previous visit. Number of subjects who had a recurrence event of the subjects who completed the study by treatment Group. | The overall study recurrence rate was 10% study-wide (2 of 20 subjects), with one Besivance subject (11%), and one Polytrim subject (9%) experiencing recurrence. | Posted | Number | Recurrence Subjects | Baseline to Week 16 (Closeout Visit ) |
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| Secondary | Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO | Subjects who experience recurrence were re-treated as if they were a new patient, with the same study medication, were followed up then classified as "Treatment Success" or "Treatment Failure" according to study protocol. | Posted | Number | participants | Baseline to Week 16 (Closeout Visit) |
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| Secondary | Treatment Failure | Possible treatment failure at a follow-up examination is operationally defined as follows: if the physician-grading scale of NLDO is worse than or same as the prior visit at any given follow-up visit, possible treatment failure then exists. Treatment Failure occurred if at visit #1 (2-week visit), the physician-grading scale of NLDO is worse than or same as the baseline visit. Treatment failure can also occur at recurrence visit #1 if the NLDO grading scale is worse or the same as compared to the previous visit. Subjects who meet the criteria for treatment failure were withdrawn from the study by the principal investigator and no additional data was collected. Subjects were referred for continued care. | Posted | Number | Number of Treatment Failures | Baseline to the time of failure or Week 16 (Closeout Visit) |
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| Secondary | Medication Safety Outcomes | During each study visit, the Principal Investigator will evaluate any possible adverse events by assessing clinical complaints and symptoms that are experienced by subjects and observed by the parent(s)/legal guardian(s), including findings in external, lacrimal duct system and anterior segment using slit lamp and fundus exam using indirect ophthalmoscope by principal investigator, as well as clinical signs including findings in external, nasolacrimal duct system and anterior segment using slit lamp and fundus exam using indirect ophthalmoscope by principal investigator. | No safety issues were reported | Posted | Number | Number of Adverse Events | Baseline to Week 16 (Closeout Visit ) |
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| Post-Hoc | Number of Subjects Treated Successfully at Close-Out Visit (Week 16) | Treatment Success is defined as a grade of 0 or improvement by 2 or more compared to the prior visit. | Posted | Number | Number of Treatment Success | Baseline to Week 16 (Close-Out Visit) |
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Baseline to Closeout Visit (Week 16)
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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) |
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| EG000 | Besivance Treatment Group | Subjects randomized to the Besivance treatment group. | 0 | 9 | 0 | 9 | ||
| EG001 | Polytrim Treatment Group | Subjects randomized to the Polytrim treatment group. | 0 | 11 | 0 | 11 |
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Limitations include the small sample size which was reduced by participant drop out.We enrolled 24 subjects, completed and collected primary outcome measure data on 20.The recurrence rate was low at 10% (2 subjects), limiting secondary data analysis.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suqin Guo, MD | NJMS, Rutgers University | 973-972-2031 | guos1@njms.rutgers.edu |
| ID | Term |
|---|---|
| C522124 | besifloxacin |
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| >=65 years |
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| Male |
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| Number of Treatment Failure |
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