权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

Safety and Efficacy of Single-use Cliradex Pads for Ocular Mites

一次性 Cliradex 眼螨垫的安全性和功效

基本信息

批准号：
8539626
负责人：
SCHEFFER CG TSENG
金额：
$ 63.75万
依托单位：
TISSUETECH, INC.
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-07-01 至 2017-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8539626
关键词：
Adult Adverse event Biological Assay Blepharitis Clinical Clinical Research Controlled Clinical Trials Cornea Cosmetics Data Development Diagnostic Procedure Disadvantaged Double-Blind Method Drug Formulations Exclusion Exhibits Eye Eye diseases Eyelash FDA approved Face Glass Goals Grant Home environment In Vitro Incidence Inflammation Inflammatory Investigational New Drug Application Lesion Life Cycle Stages Marketing Melaleuca alternifolia Methods Microscopic Mites Modification Monitor Mono-S Ointments Patch Tests Patients Phase Placebos Plague Plant Leaves Play Randomized Regimen Role Rosacea Safety Sampling Self Administration Signs and Symptoms Site Skin Steam Symptoms Tea Tea Tree Oil Terpenes Testing Therapeutic Agents Trees Vision Volatile Oils aging population antimicrobial base clinical efficacy clinical research site conventional therapy cytotoxic human subject improved irritation killings ocular surface preclinical safety safety study

项目摘要

DESCRIPTION (provided by applicant): Demodex mites are microscopic ectoparasites that commonly infest the pilosebaceous unit of the skin. Uncontrolled overgrowth of mites has been implicated in causing papulopustular lesions in the skin, rosacea in the face, and blepharitis in the eye. Blepharitis (lid margin inflammation) associated with mite-harboring cylindrical dandruff in eyelashes is one of the most common eye diseases. The conventional treatment, using lid scrub with Baby Shampoo, is ineffective in eradicating ocular Demodex infestation (demodicosis). However, we have discovered that tea tree oil (TTO), a natural essential oil steam-distilled from the leaf of Melaleuca alternifolia, is effective in treating ocular demodicosi. Our preliminary clinical studies showed that the lid scrub regimen, based on a weekly office scrub with 50% TTO followed by daily home scrubs with tea tree shampoo, is effective in resolving irritating symptoms and ocular surface inflammation, as well as in improving vision in a number of patients. However, this treatment was not convenient for patient self-administration and resulted in ocular irritation in some patients. We have completed the following three Aims described in Phase I application to identify the most active ingredient in TTO responsible for killing Demodex mites and to eliminate the remaining ingredients in order to develop single-use Cliradex(R) Pads to facilitate the patient's ease of self- administration (Aim 1), to complete preclinical safety studies to verify that this new Cliradex(R) Pad was non- irritative based on an in vitro cytotoxic assay and 9 Repeated Insult Patch Test in human subjects (Aim 2), and to demonstrate that the new formulation exerts potent anti-microbial effects, thus eliminating the need to add preservatives, and is stable both in the glass jar and in the packette (Aim 3). In this Phase II application, we propose to conduct randomized, double-blind, controlled clinical trials to demonstrate the safety and efficacy of the single-use Cliradex(R) Pad compared to the Placebo Pad for treating ocular demodicosis. In Aim 1, at a single site, we will determine the optimal regimen for applying Cliradex(R) Pads to achieve maximal reduction in ocular Demodex counts and clinical improvement in patients' symptoms and signs without eliciting adverse events by comparing three different lid scrub regimens for a period of 1 month. In Aim 2, at multiple sites, we will use the lid scrub regimen optimized in Aim 1 to determine the optimal duration to achieve maximal reduction of ocular Demodex counts and maximal efficacy in resolving patient's inflammatory symptoms and signs. Accomplishment of these two Aims will allow us to gather data for Phase III FDA pivotal studies so that an NDA can be submitted to for the ultimate goal of developing the first FDA-approved prescription ophthalmic therapy containing the most active ingredient of TTO to eradicate ocular demodicosis.

描述(申请人提供)：蠕形螨是一种微小的体外寄生虫，通常侵袭皮肤的毛皮脂腺单位。不受控制的螨类过度生长会导致皮肤丘疹丘疹、面部酒渣鼻和眼睑发炎。眼缘炎是最常见的眼科疾病之一，与睫毛上长满粉尘的柱状头皮屑有关。传统的治疗方法是用婴儿洗发水擦洗眼盖，但在根除眼部蠕形螨感染(蠕形螨病)方面效果不佳。然而，我们发现茶树油(TTO)，一种从互叶千层叶中水蒸气蒸馏的天然精油，对治疗眼部蠕形螨病有效。我们的初步临床研究表明，基于每周一次50%TTO的办公室擦洗，然后每天用茶树洗发水进行家居擦洗的眼睑擦洗方案，在缓解刺激性症状和眼表炎症方面有效，并在许多患者中改善视力。然而，这种治疗方法不利于患者自我给药，并导致部分患者出现眼部刺激。我们已经完成了第一阶段申请中描述的以下三个目标：确定TTO中负责杀灭蠕形螨的最有效成分，并消除剩余成分，以开发一次性使用的Cliradex(R)垫，以促进患者的自我给药(目标1)，完成临床前安全性研究，以验证这种新的Cliradex(R)垫是无刺激性的，基于体外细胞毒性试验和9次人体重复损伤斑贴试验(目标2)，并证明新配方具有强大的抗微生物效果，从而消除了添加防腐剂的需要。并且在玻璃瓶和包装盒中都是稳定的(目标3)。在这第二阶段应用，我们建议进行随机、双盲、对照临床试验证明一次性使用的Cliradex(R)Pad与安慰剂Pad相比在治疗眼球蠕形虫病方面的安全性和有效性。在目标1中，我们将通过对三种不同的眼睑擦洗方法进行为期1个月的比较，在单一地点确定使用Cliradex(R)衬垫的最佳方案，以最大限度地减少眼部蠕形虫数量，并在临床上改善患者的症状和体征，而不会引发不良事件。在目标2中，我们将在多个地点使用目标1中优化的眼睑擦洗方案，以确定实现最大限度减少眼部蠕形螨数量和最大限度地缓解患者炎症症状和体征的最佳持续时间。这两个目标的实现将使我们能够为FDA第三阶段的关键研究收集数据，以便提交NDA，以最终目标是开发首个FDA批准的处方眼科疗法，其中包含TTO的最有效成分，以根除眼部蠕形螨病。