Demodex Blepharitis Treatment Study (DBTS)

TissueTech

Status and phase: Completed; Phase 1

Conditions: Chronic Blepharitis

Treatments: Drug: Terpinen-4-ol; Other: Placebo

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT01647217

P012-01

2R44EY019586-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 17 patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 2 patient groups, including a placebo group

Terpinen-4-ol Treatment Arm

Experimental group

Description:

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.

Treatment:

Drug: Terpinen-4-ol

Placepo Pads Contol Arm

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo