Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children

This study has been completed.
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01431170
First received: September 6, 2011
Last updated: June 15, 2016
Last verified: March 2016
Results First Received: December 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Congenital Nasolacrimal Duct Obstruction
Interventions: Drug: Besivance Treatment Group
Drug: Polytrim Treatment Group

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Besivance Treatment Group Subjects receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily for 10 days.
Polytrim Treatment Group Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily for 10 days.

Participant Flow:   Overall Study
    Besivance Treatment Group     Polytrim Treatment Group  
STARTED     12     12  
COMPLETED     9     11  
NOT COMPLETED     3     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Besivance Treatment Group Subjects received Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.
Polytrim Treatment Group Subjects received Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.
Total Total of all reporting groups

Baseline Measures
    Besivance Treatment Group     Polytrim Treatment Group     Total  
Number of Participants  
[units: participants]
  12     12     24  
Age  
[units: participants]
     
<=18 years     12     12     24  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: days]
Mean (Standard Deviation)
  110.83  (93.05)     158.58  (110.62)     134.71  (102.90)  
Gender  
[units: participants]
     
Female     5     8     13  
Male     7     4     11  
Region of Enrollment  
[units: participants]
     
United States     12     12     24  



  Outcome Measures
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1.  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.   [ Time Frame: Baseline to Week 8 ]

2.  Secondary:   Number of Recurrences by Randomization Group   [ Time Frame: Baseline to Week 16 (Closeout Visit ) ]

3.  Secondary:   Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO   [ Time Frame: Baseline to Week 16 (Closeout Visit) ]

4.  Secondary:   Treatment Failure   [ Time Frame: Baseline to the time of failure or Week 16 (Closeout Visit) ]

5.  Secondary:   Medication Safety Outcomes   [ Time Frame: Baseline to Week 16 (Closeout Visit ) ]

6.  Post-Hoc:   Number of Subjects Treated Successfully at Close-Out Visit (Week 16)   [ Time Frame: Baseline to Week 16 (Close-Out Visit) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Suqin Guo, MD
Organization: NJMS, Rutgers University
phone: 973-972-2031
e-mail: guos1@njms.rutgers.edu



Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01431170     History of Changes
Other Study ID Numbers: 0120110184
Study First Received: September 6, 2011
Results First Received: December 23, 2015
Last Updated: June 15, 2016
Health Authority: United States: Food and Drug Administration