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completed
Phase 1

NCT01647217

Demodex Blepharitis Treatment Study

Sponsored by BioTissue Holdings, Inc

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.

Locations (1)

Ocular Surface Center

Miami, Florida, United States

Why you can trust this information
Registry sourcesclinicaltrials_gov
Source last updated7/26/2017
Clintriva indexed9/27/2026, 9:23:16 PM
Registry records1
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Identity-resolution confidence concerns registry/entity resolution and does not determine clinical eligibility.

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Quick Facts
Start DateFeb 1, 2014
CompletionJun 1, 2015
Enrollment0/17
CountryUnited States

Conditions

Chronic Blepharitis
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