Demodex Blepharitis Treatment Study

BioTissue Holdings, Inc17 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Blepharitis

Interventions

Terpinen-4-olDRUG

Lid scrub once or twice per day for one month.

PlaceboOTHER

Lid scrub once or twice per day for one month

Eligibility

Sex: ALLMin age: 15 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ocular Surface Center

Miami, Florida, United States

Outcomes

Primary Outcomes

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".

Time frame: 6 weeks

Secondary Outcomes

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).

Time frame: Baseline and 6 weeks

Data from ClinicalTrials.gov

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