Safety and Efficacy of Single-use Terpinen-4-ol Pads for Treating Ocular Mites A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in the Number of Demodex Mites
研究概览
简要总结
This is a randomized clinical trial to determine the safety and efficacy of terpinen-4-ol (T4O), the most active ingredient of tea tree oil (TTO), in eradicating ocular demodicosis (reducing ocular demodex counts and achieving the clinical improvement with minimal or no irritation).
详细描述
Demodex blepharitis is one of the most common causes of chronic blepharitis. The investigators preliminary clinical study showed that lid scrub with TTO was effective in resolving chronic blepharoconjunctivitis; however, it was not convenient for self-administration and caused irritation in some patients. Preclinical safety studies have verified that T4O is less irritant. In this study, the investigators will determine the optimal regimen of T4O Pads.
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
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic Demodex blepharitis for duration of at least 3 months.
- •Age range: 15-80 years old.
- •Both genders and all ethnic groups comparable with the local community.
- •Able to understand and willing to sign a written informed consent
- •Able and willing to cooperate with the investigational plan.
- •Able and willing to complete all mandatory follow-up visits.
排除标准
- •Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.
- •Children under
- •Pregnant women or expecting to be pregnant during the study.
- •Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.
- •Concomitant use of ophthalmic topical medications (excluding non-preserved tear substitutes).
- •Concomitant use of systemic antibiotics or steroids.
- •Contact lens wear (unless discontinued for ≥ 30 days before randomization)
- •Active ocular infection or allergy
- •Unable to close eyes or uncontrolled blinking
- •Presence of aqueous tear deficient dry eye defined by the Fluorescein Clearance Test as less than 3 mm wetting in 1-minute Schirmer test with anesthesia.
- •Previous allergic reaction to TTO-containing products or cosmetic fragrance.
研究组 & 干预措施
Terpinen-4-ol Treatment Arm
8 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (3 / 5 patients) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.
干预措施: Terpinen-4-ol (Drug)
Placepo Pads Contol Arm
9 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 / 4 patients) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.
干预措施: Placebo (Other)
结局指标
主要结局
Change in the Number of Demodex Mites
时间窗: 6 weeks
Change in mites count after treatment compared to the baseline data. If the mites' count remains zero during the last two visits, it is considered "complete eradication". Patients without achieving complete eradication will be categorized as "incomplete eradication".
次要结局
- Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia(Baseline and 6 weeks)