Overview

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.