Demodex Blepharitis Treatment Study

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tissue Tech Inc.
• Collaborator: National Eye Institute (NEI)

Criteria

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.