Trial · NCT01431170
Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children
NCT01431170, Phase 1, Completed, Rutgers, The State University of New Jersey; results first posted 2016-06-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children. Trials, record NCT01431170. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01431170
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children
- NCT number
- NCT01431170
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 24 participants, actual
- Lead sponsor
- Rutgers, The State University of New Jersey
- Conditions
- Congenital Nasolacrimal Duct Obstruction
- Interventions
- Besivance Treatment Group, Polytrim Treatment Group
- First posted
- 2011-09-09
- Last updated
- 2016-07-14
- Results first posted
- 2016-06-09
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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. | Baseline to Week 8 | The NLDO grading scale in the study eye at every visit. The scale ranges from 0 to +4: * 0: No tearing and discharge. * 1: Tearing, moderate mucous discharge around nasolacrimal punctum * 2: Moderate redness of the medial eyelid with mucous discharge * 3: Redness and swelling of the eyelid with mucopurulent discharge * 4: Redness and swelling of eyelid with purulent discharge 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. |
| Secondary | Number of Recurrences by Randomization Group | Baseline to Week 16 (Closeout Visit ) | 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. |
| Secondary | Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO | Baseline to Week 16 (Closeout Visit) | 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. |
| Secondary | Treatment Failure | Baseline to the time of failure or Week 16 (Closeout Visit) | 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. |
| Secondary | Medication Safety Outcomes | Baseline to Week 16 (Closeout Visit ) | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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. | Baseline to Week 8 | participants | NUMBER | |
| SECONDARY | Number of Recurrences by Randomization Group | Baseline to Week 16 (Closeout Visit ) | 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. | Recurrence Subjects | NUMBER |
| SECONDARY | Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO | Baseline to Week 16 (Closeout Visit) | participants | NUMBER | |
| SECONDARY | Treatment Failure | Baseline to the time of failure or Week 16 (Closeout Visit) | Number of Treatment Failures | NUMBER | |
| SECONDARY | Medication Safety Outcomes | Baseline to Week 16 (Closeout Visit ) | No safety issues were reported | Number of Adverse Events | NUMBER |
| POST_HOC | Number of Subjects Treated Successfully at Close-Out Visit (Week 16) | Baseline to Week 16 (Close-Out Visit) | Number of Treatment Success | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | Besivance Treatment Group | Number of Treatment Success | 7 | participants | |
| 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. | Polytrim Treatment Group | Number of Treatment Success | 10 | participants | |
| 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. | Besivance Treatment Group | Number of Recurrence | 1 | participants | |
| 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. | Polytrim Treatment Group | Number of Recurrence | 1 | participants | |
| 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. | Besivance Treatment Group | Number of Treatment Failure | 1 | participants | |
| 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. | Polytrim Treatment Group | Number of Treatment Failure | 0 | participants | |
| Number of Recurrences by Randomization Group | Besivance Treatment Group | 1 | Recurrence Subjects | ||
| Number of Recurrences by Randomization Group | Polytrim Treatment Group | 1 | Recurrence Subjects | ||
| Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO | Efficacy of Besivance Treatment Group | Number of Treatment Success after Recurrence | 1 | participants | |
| Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO | Efficacy of Polytrim Treatment Group | Number of Treatment Success after Recurrence | 0 | participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Besivance Treatment Group | 12 | |
| Overall Study | STARTED | Polytrim Treatment Group | 12 | |
| Overall Study | COMPLETED | Besivance Treatment Group | 9 | |
| Overall Study | COMPLETED | Polytrim Treatment Group | 11 | |
| Overall Study | NOT COMPLETED | Besivance Treatment Group | 3 | |
| Overall Study | NOT COMPLETED | Polytrim Treatment Group | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Besivance Treatment Group | ||
| Total, all-cause mortality | Polytrim Treatment Group | ||
| Total, other adverse events | Besivance Treatment Group | 0 | 9 |
| Total, other adverse events | Polytrim Treatment Group | 0 | 11 |
| Total, serious adverse events | Besivance Treatment Group | 0 | 9 |
| Total, serious adverse events | Polytrim Treatment Group | 0 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Besivance Treatment Group vs Polytrim Treatment Group: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01431170
GET https://conductscience.org/api/trials/v1/NCT01431170/registered