Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01431170 | Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children | PHASE1 | COMPLETED | 24 | — | — | Sep 1, 2011 | Jun 1, 2014 | Jul 14, 2016 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Besivance Treatment Group | EXPERIMENTAL | Besivance™ ophthalmic suspension, 0.6% |
| Polytrim Treatment Group | ACTIVE_COMPARATOR | Polytrim ophthalmic solution |
| Name | Type | Description |
|---|---|---|
| Besivance Treatment Group | DRUG | Subjects Receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days. |
| Polytrim Treatment Group | DRUG | Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days. |
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 Investiga...