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
Sponsor study identifier
interventional
24
1 country
1
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
September 6, 2011
Actual (reported)September 9, 2011
Actual (reported)June 2014
Actual (reported)June 2014
Actual (reported)June 9, 2016
Actual (reported)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: * 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.
Baseline to Week 8
Number of Recurrences by Randomization Group
Baseline to Week 16 (Closeout Visit )
Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO
Baseline to Week 16 (Closeout Visit)
Treatment Failure
Baseline to the time of failure or Week 16 (Closeout Visit)
Medication Safety Outcomes
Baseline to Week 16 (Closeout Visit )
Besivance™ ophthalmic suspension, 0.6%
Polytrim ophthalmic solution
Subjects Receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.
Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.
Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School
Newark, New Jersey, 07103, United States
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.
Suqin Guo, M.D.
Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School
24 participants (actual enrollment reported by the registry).
First Submitted
September 6, 2011
First Posted
September 9, 2011
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)Last Updated
July 14, 2016
Results First Posted
June 9, 2016
Record last verified: 2016-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: