Phase 1
N=17
Demodex Blepharitis Treatment Study
Chronic Blepharitis
Bottom Line
View on ClinicalTrials.gov: NCT01647217 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Change in the Number of Demodex Mites — -3; -0.4 Mites
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Terpinen-4-ol (Drug); Placebo (Other)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- BioTissue Holdings, Inc
- Primary completion
- Jun 2015
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 | — |
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).
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.