Demodex Blepharitis Treatment Study
Completed · Phase 1 · Has a placebo group
Conditions studied: Chronic Blepharitis
In brief
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).
Key facts
- Study ID
- NCT01647217
- Run by
- BioTissue Holdings, Inc
- People needed
- 17
- Starts
- 2014-02-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2017-07-26
Who can join
Age: 15 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Ocular Surface Center — Miami, Florida, United States
Full record on ClinicalTrials.gov
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