Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children
|Congenital Nasolacrimal Duct Obstruction||Drug: Besivance Treatment Group Drug: Polytrim Treatment Group||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- 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:
- 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.
- 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.
- 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.
- 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.
- 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.
|Study Start Date:||September 2011|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Besivance Treatment Group
Besivance™ ophthalmic suspension, 0.6%
Drug: Besivance Treatment Group
Subjects Receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.
Other Name: Besifloxacin,Besivance
Active Comparator: Polytrim Treatment Group
Polytrim ophthalmic solution
Drug: Polytrim Treatment Group
Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.
Other Name: polymyxin b/trimethoprim - ophthalmic
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431170
|United States, New Jersey|
|Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School|
|Newark, New Jersey, United States, 07103|
|Principal Investigator:||Suqin Guo, M.D.||Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School|