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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.)
排除标准
- •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
研究组 & 干预措施
Besivance Treatment Group
Besivance™ ophthalmic suspension, 0.6%
干预措施: Besivance Treatment Group (Drug)
Polytrim Treatment Group
Polytrim ophthalmic solution
干预措施: Polytrim Treatment Group (Drug)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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))
- Medication Safety Outcomes(Baseline to Week 16 (Closeout Visit ))
- Treatment Failure(Baseline to the time of failure or Week 16 (Closeout Visit))