- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01431170
Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children
A Prospective, Double-Blinded, Parallel-Group, Randomized Study to Assess the Safety and Efficacy of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New Jersey
-
Newark, New Jersey, United States, 07103
- Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Persons who have been diagnosed with congenital Nasolacrimal Duct Obstruction (NLDO) with infection by the Principal Investigator
- Both males and females
- Persons who are age of 1 to 12 months at time of diagnosis (time of diagnosis is defined as when the Principal Investigator makes clinical diagnosis.)
Exclusion Criteria:
- Persons who have received any antibiotic treatment for NLDO with infection for more than 2 week in the past 4 weeks.
- Persons who are currently receiving systemic antibiotic treatment that cannot be discontinued.
- Persons with any other ocular anomalies that could potentially interfere with interpretation of study results.
- Persons who have had any prior nasolacrimal duct system procedures such as stenting or probing.
- Persons who have previously participated in any clinical trial(s) of Besivance™
- Persons who have participated in any other clinical trial(s) of any investigational agent(s) within 30 days prior to the Baseline visit
- Persons who have any chronic diseases that might interfere with study participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Besivance Treatment Group
Besivance™ ophthalmic suspension, 0.6%
|
Subjects Receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.
Other Names:
|
Active Comparator: Polytrim Treatment Group
Polytrim ophthalmic solution
|
Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: Baseline to Week 8
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Recurrences by Randomization Group
Time Frame: 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. |
Baseline to Week 16 (Closeout Visit )
|
Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO
Time Frame: 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.
|
Baseline to Week 16 (Closeout Visit)
|
Treatment Failure
Time Frame: 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. |
Baseline to the time of failure or Week 16 (Closeout Visit)
|
Medication Safety Outcomes
Time Frame: 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.
|
Baseline to Week 16 (Closeout Visit )
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Suqin Guo, M.D., Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Lacrimal Apparatus Diseases
- Lacrimal Duct Obstruction
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Folic Acid Antagonists
- Anti-Dyskinesia Agents
- Anti-Infective Agents, Urinary
- Renal Agents
- Cytochrome P-450 CYP2C8 Inhibitors
- Fluoroquinolones
- Besifloxacin
- Trimethoprim
- Polymyxins
- Polymyxin B
Other Study ID Numbers
- 0120110184
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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