Demodex Blepharitis Treatment Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Safety and Efficacy of Single-use Terpinen-4-ol Pads for Treating Ocular Mites A Randomized Clinical Trial

Conditions
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Chronic Blepharitis

Intervention / Treatment
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* Drug: Terpinen-4-ol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 15. 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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Terpinen-4-ol Treatment Arm<br>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. | Drug: Terpinen-4-ol<br>* Lid scrub once or twice per day for one month.<br>* Other names: T4O;|
| Placebo Comparator: Placepo Pads Contol Arm<br>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. | Other: Placebo<br>* Lid scrub once or twice per day for one month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Number of Demodex Mites | 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia | Lid margin redness and bulbar conjunctival hyperemia were each assessed using an ordered categorical value ranging from 0 (None) to 3 (Severe). The two scores were summed to obtain the final score, which ranges from 0 (None) to 6 (Severe). | Baseline and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blepharitis, Demodex, Mites, Tea Tree oil, Terpinen