NCT00420628已完成4 期
A Safety and Efficacy Study of Zylet® (Loteprednol Etabonate 0.5% and Tobramycin 0.3% Ophthalmic Suspension) Compared to Vehicle in the Management of Lid Inflammation (Chalazion/Hordeolum) in Pediatric Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Treatment Emergent Adverse Events
研究概览
简要总结
A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child, 0 to 6 years of age, any sex and race
- •Subject must have a clinical diagnosis of lid inflammation (e.g. Chalazion/Hordeolum) in at least one eye. If both eyes are diagnosed with lid inflammation, both eyes will be treated
- •In good health (no current or past relevant medical history), based on the judgment of the investigator
- •Parent/guardian is able and willing to follow instructions and provide informed consent
排除标准
- •Known hypersensitivity to corticosteroids, loteprednol etabonate, or any component of the study medication
- •Known hypersensitivity to aminoglycosides, tobramycin, or any component of the study medication
- •Use of concurrent ocular therapy with non-steroidal anti-inflammatory agent (NSAID), mast cell stabilizer, antihistamine, or decongestant within 48 hours before and during the study
- •Use of oral or topical ophthalmic corticosteroids (other than study medication) within 48 hours before and during the study
- •Use of systemic antibiotics within 72 hours before and during the 14 day study medication treatment duration
- •Use of topical ophthalmic antibiotics (other than the study medication) within 72 hours before and during the study
- •History of ocular surgery, including laser procedures, within the past six months
- •Anticipation that surgical intervention for lid inflammation will be required prior to completion of the study
- •Subjects with suspected vernal conjunctivitis, glaucoma of any kind, viral or bacterial conjunctivitis, preseptal cellulitis requiring systemic antibiotics, dacryocystitis, uveitis, or any other disease conditions that could interfere with the safety and efficacy evaluations of the study medication
- •History of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study
- •Participation in an ophthalmic drug or device research study within 30 days prior to entry in this study
- •Unlikely to comply with the protocol instructions for any reason
研究组 & 干预措施
Loteprednol/Tobramycin
Experimental
0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension
干预措施: loteprednol etabonate/tobramycin opthalmic suspension (Drug)
Vehicle
Placebo Comparator
Vehicle
干预措施: vehicle (Drug)
结局指标
主要结局
Treatment Emergent Adverse Events
时间窗: day 1, day 8, day 15
Study eye - Safety Population, At all visits 1,2,3
次要结局
- Investigators Global Assessment of the Clinical Condition(Visit 3, day 8)
- Assessment of Ocular Signs in the Study Eye - Visit 1(Visit 1 (day 1))
- Assessment of Ocular Signs in the Study Eye - Visit 2(Visit 2 (day 8))
- Assessment of Ocular Signs in the Study Eye - Visit 3(Visit 3 (day 15))
研究者
研究点 (1)
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