TCTR20200710004尚未招募2 期
Efficacy, Safety and Tolerability of liposomal latanoprost (LIPOLAT®) injection for treatment of Lower Eyelid Steatoblepharon
Peregrine Opthalmic Pte Ltd0 个研究点目标入组 24 人开始时间: 2020年7月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1) Subject has mild to moderate eyebags (as defined by certain grading confirmed by oculoplastic/plastic surgeon specialist. Grade 1-3.
- •2) Subject willing to comply with study requirements.
- •3) Subject who has signed an approved informed consent form.
排除标准
- •1) Patient with asthma.
- •2) Patient who is pregnant or nursing or unable to use non-hormonal birth control.
- •3) Patient who is unwilling or unable to give informed consent, or unable to return for scheduled protocol visits.
- •4) Patient who is already enrolled in another study or completed their participation in another study within 30 calendar days of the screening exam.
- •5) Known allergy to prostaglandin analogues
- •6) Previous history of lower eyelid blepharoplasty, dermal filler injection, or other treatment, for example dermal laser, intense pulse light, radiofrequency or topical drugs for treatment of eyebags
- •7) Known glaucoma patient who has used or will use topical prostaglandin as a form of treatment
- •8) Topical, periocular or intraocular steroid use or systemic steroid use anytime within three months of the procedure.
- •9) Active thyroid eye disease, any orbital inflammatory diseases, any orbital trauma, any orbital tumor.
- •10) Any ocular inflammations or other active ophthalmic conditions that could confound study results.
- •11) Ocular pathology or medical condition for which, in the investigator's judgment, the following factors would either place the subject at increased risk of complications or contraindicate device implantation or interfere with compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits),
- •a. uncontrolled systemic disease (e.g. diabetes, hypertension) that could compromise their participation in the study.
- •b. Disorders that pose a fall risk, as well as compromise ability to take a visual field exam and take glaucoma medications (e.g., Parkinson's disease),
- •c. inability to discontinue use of blood thinners within the surgeon’s standard preoperative or postoperative instructions.
研究者
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