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

NCT01431170 | Completed Phase 1 Results DMC

• 1 other identifier: 0120110184
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Nasolacrimal Duct Obstruction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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 )

Study Arms (2)

Besivance Treatment Group

EXPERIMENTAL

Besivance™ ophthalmic suspension, 0.6%

Drug: Besivance Treatment Group

Polytrim Treatment Group

ACTIVE COMPARATOR

Polytrim ophthalmic solution

Drug: Polytrim Treatment Group

Interventions

Besivance Treatment Group DRUG

Subjects Receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.

Also known as: Besifloxacin,Besivance

Besivance Treatment Group

Polytrim Treatment Group DRUG

Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.

Also known as: polymyxin b/trimethoprim - ophthalmic

Polytrim Treatment Group

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (1)

Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Interventions

besifloxacin

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.

Results Point of Contact

• Title: Suqin Guo, MD
• Organization: NJMS, Rutgers University

guos1@njms.rutgers.edu

973-972-2031

Study Officials

• Suqin Guo, M.D.

  Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: September 9, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 14, 2016
• Results First Posted: June 9, 2016

Record last verified: 2016-03

Locations

US (1)