Phase 1
Completed N=17
Demodex Blepharitis Treatment Study
Chronic Blepharitis
Source: ClinicalTrials.gov NCT01647217 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Change in the Number of Demodex Mites — -3; -0.4 Mites
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Number of Demodex Mites |
-3; -0.4 | — |
| SECONDARY Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia |
-2.3; -3.1 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01647217). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.