Congenital Nasolacrimal Duct ObstructionPhase 1NCT01431170
Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children
A Phase 1 study testing Besivance Treatment Group and Polytrim Treatment Group in people with Congenital Nasolacrimal Duct Obstruction, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Congenital Nasolacrimal Duct Obstruction
- What is being tested?
- Besivance Treatment Group and Polytrim Treatment Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jun 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School
Newark, New Jersey, 07103
About this study
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
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.
Read the detailed description
The primary objective of this study is to evaluate the safety and efficacy of Besivance™ as an antibiotic treatment for congenital nasolacrimal duct obstruction with infection in children. The primary outcome measure is the change from baseline on the physician rated scale of Nasolacrimal Duct Obstruction (NLDO)with infection to follow-up visit #2 (Week 8) or at the time of treatment failure, if earlier.
- Conditions
- Congenital Nasolacrimal Duct Obstruction
- Being tested
- Besivance Treatment Group, Polytrim Treatment Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Besivance Treatment GroupDrug
Also called Besifloxacin,Besivance
Subjects Receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.
Polytrim Treatment GroupDrug
Also called polymyxin b/trimethoprim - ophthalmic
Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Besivance Treatment Group | Experimental | Besivance™ ophthalmic suspension, 0.6% Receives: Drug: Besivance Treatment Group |
| Polytrim Treatment Group | Active comparator | Polytrim ophthalmic solution Receives: Drug: Polytrim Treatment Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 8
Secondary outcomes (4)
Number of Recurrences by Randomization Group
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.
Measured: Baseline to Week 16 (Closeout Visit )
Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO
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.
Measured: Baseline to Week 16 (Closeout Visit)
Treatment Failure
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.
Measured: Baseline to the time of failure or Week 16 (Closeout Visit)
Medication Safety Outcomes
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.
Measured: Baseline to Week 16 (Closeout Visit )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congenital Nasolacrimal Duct ObstructionStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Sponsor
- Investigators
- Suqin Guo, M.D., Principal investigator, Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431170
- Sponsor's protocol ID
- 0120110184
- Status last verified
- Mar 2016
- First submitted
- 6 Sep 2011
- Last updated
- 14 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01431170
- Acronym / sponsor ID
- 0120110184
- Conditions
- Congenital Nasolacrimal Duct Obstruction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- Sep 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 9 Sep 2011 (estimated)
- Results
- Posted 9 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of this study is to evaluate the safety and efficacy of Besivance™ as an antibiotic treatment for congenital nasolacrimal duct obstruction with infection in children. The primary outcome measure is the change from baseline on the physician rated scale of Nasolacrimal Duct Obstruction (NLDO)with infection to follow-up visit #2 (Week 8) or at the time of treatment failure, if earlier.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Besivance Treatment Group | Experimental | Drug: Besivance Treatment GroupBesivance™ ophthalmic suspension, 0.6% |
| Polytrim Treatment Group | Active comparator | Drug: Polytrim Treatment GroupPolytrim ophthalmic solution |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.)
Key exclusion criteria (7 listed)
- 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™
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Besivance Treatment GroupAlso: Besifloxacin,BesivanceSubjects Receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days. | Drug | Besivance Treatment Group |
| Polytrim Treatment GroupAlso: polymyxin b/trimethoprim - ophthalmicSubjects receive Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days. | Drug | Polytrim Treatment Group |
Primary outcome
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.
4 secondary outcomes
Number of Recurrences by Randomization Group
Time frame: 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)
Treatment Failure
Time frame: Baseline to the time of failure or Week 16 (Closeout Visit)
Medication Safety Outcomes
Time frame: Baseline to Week 16 (Closeout Visit )
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Congenital Nasolacrimal Duct Obstruction
Active, not recruitingPhase 4
Efficacy and Safety of Piclosept in the Complex Treatment of Neonatal Dacryocystitis
Neonatal Dacryocystitis, Congenital Nasolacrimal Duct Obstruction
Not yet recruiting
Outcomes of Early Lacrimal Probing Versus Lacrimal Sac Massage in Infants With Congenital Nasolacrimal Duct Obstruction
Lacrimal Duct Obstruction
Not yet recruiting
Effect of Standardized Lacrimal Sac Massage Compared With Probing for Congenital Lacrimal Duct Obstruction
Nasolacrimal Duct Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suqin Guo, M.D. principal investigator
Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Besivance Treatment Group and Polytrim Treatment Group in people with Congenital Nasolacrimal Duct Obstruction, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.