A Multi-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of SUN 131 Transdermal System (TDS) as Compared to Placebo TDS in Adult Patients With a Chalazion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Complete Response
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of SUN-131 1.5% TDS as compared with placebo TDS in the treatment of chalazion based on the proportion of subjects that have complete response. Complete response is defined as the absence of any significant clinical signs of a chalazion with possible scaring or skin defects resulting from healing of the chalazion allowed.
详细描述
Subjects will be randomly assigned to receive one of the following treatments in the affected eyelid:
- SUN-131 1.5% TDS (n=30)
- Placebo TDS (n=30)
At baseline prior to application of the TDS an assessment will be performed on both the subject's eyes including the chalazion site itself.
All subjects will return to the site on Days 8±1, 15±2 and 23±2 for evaluations. During the the 23±2 visit, a clinical evaluation will be performed to determine if the chalazion is still present.
There will also be follow up on Day 29±3, and on Day 50 visit (study days 47 to 60) to evaluate the safety and durability of the effect of the SUN-131 1.5% TDS.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older of either sex and any race
- •Chalazion with visible single granuloma in an upper or lower eyelid. If more than one eyelid is diagnosed with a chalazion, the most inflammatory chalazion shall be selected as the study eyelid. Other eyelids containing a chalazion will not be treated with investigational product in this trial.
- •Chalazion intended for study treatment presents no more than 3 weeks based on subject history.
- •Normal lid function
- •Must be willing and able to correctly apply and wear a transdermal patch to the eyelid for 16±4 hours each day for repeated application
- •Female subjects of childbearing potential must have a negative urine pregnancy test on Day 1, and must agree to use method of contraception from the start of study drug use and for 30 days after discontinuation of study drug. Approved methods of contraception include, an IUD with spermicide, a female condom with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, use of a condom with spermicide by sexual partner or a sterile sexual partner or oral contraceptives.
- •If male, subjects must be sterile or willing to use an approved method of contraception from the time of study drug administration to 30 days after discontinuation of study drug. Males must be willing to refrain from sperm donation within 30 days after study drug treatment.
- •Are able and willing to attend all study visits and follow all study instructions.
- •Have signed written informed consent before undergoing any study related procedures and is willing to comply with all study procedures.
- •Avoid wearing contact lenses or any new facial cosmetic products during the study trial period.
排除标准
- •Chalazion which have atypical features (a recurring chalazion at the same spot, abnormal surrounding lid tissue, associated loss of tissues).
- •Chalazion at the lid margin.
- •Active ocular or eyelid infection (bacterial, viral, or fungal), any ocular or eyelid condition that in the investigator's opinion could affect the subject's health or the study parameters.
- •An abnormal skin condition on the upper and lower eyelid region of the eyelid (e.g. eczema, psoriasis, etc.) where the patches will be applied.
- •Intraocular pressure greater than 22 mmHg.
- •Diagnosed with glaucoma.
- •Use of oral and ocular therapy with a steroid within 7 days prior to administration of the study medication and during the study.
- •Female subjects who are pregnant or lactating.
- •Known allergy or sensitization to the test article or any formulation components.
- •Major non-ocular surgery within 30 days prior to Day
- •History or evidence of ocular surgery within the past 3 months and/or a history of refractive surgery within the past 6 months.
- •Planned surgery (ocular or systemic) during the trial period or within 30 days of removal of the transdermal patch.
- •Participation in an investigational study within 30 days prior to Day
- •Have any ocular condition that requires chronic use of topical ophthalmic medication (e.g., glaucoma, dry eye, allergic conjunctivitis) with exception of artificial tear drops or lubricant eye drops or that, in the investigator's opinion, prevents the safe use of the patch.
- •History of any previous functional or cosmetic eyelid surgery (including blepharopigmentation).
- •Any other condition that, in the opinion of the investigator, renders the subject unsuitable for study participation.
研究组 & 干预措施
SUN-131 1.5% TDS
Subjects will be randomly assigned to receive SUN-131 1.5% TDS for the affected eye. All patches will be worn for 16±4 hours each day for 21 days.
干预措施: SUN-131 1.5% TDS (Drug)
Placebo TDS
Placebo Patch for Blinding Purposes
干预措施: Placebo TDS (Drug)
结局指标
主要结局
Complete Response
时间窗: Day 23±2
Complete response is defined as the absence of any significant clinical signs of a chalazion with possible scaring or skin defects resulting from healing of the chalazion allowed.
次要结局
- Pain Associated with the Chalazion(Study days 47 to 60)
- Durability of Response(Study days 47 to 60)
- Change in Chalazion Erythema(Study days 47 to 60)
- Time to Complete Response of the Target Chalazion(Study days 47 to 60)
- Comparison of Adverse Event Rates and Skin Irritation between Treatment Arms(Day 23±2)
- Change in Chalazion Size(Study days 47 to 60)