Demodex Blepharitis Treatment Study
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 15 - 80 |
| Updated: | 4/2/2016 |
| Start Date: | February 2014 |
| End Date: | April 2015 |
| Contact: | Hosam El Sheha, MD, PhD |
| Email: | hoss88@gmail.com |
| Phone: | 305-274-1299 |
Safety and Efficacy of Single-use Terpinen-4-ol Pads for Treating Ocular Mites A Randomized Clinical Trial
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).
(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.
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.
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.
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