The trial titled Demodex Blepharitis Treatment Study, is sponsored by a company called Tissue Tech Inc. of Florida (who don’t seem to have a web site).
Trial NCT01647217 seeks to prove that terpinen-4-ol (T4O) is safe and effective in eradicating ocular infestation of demodex mites.
Terpinen-4-ol (T4O) is the most abundant of the 100 components of Tea Tree Oil, typically comprising 30%. In fact the international standard for Tea Tree Oil, ISO 4730 stipulates that TTO should contain between 30% and 48% of terpinen-4-ol.
Killing Demodex Mites
There is a fairly short list of chemicals that are known to kill demodex mites, TTO is near the top of the list.
A 2007 paper from Cornea told us that lib scrubs with TTO can effectively eradicate ocular demodex – and can result in objective and subjective improvements in symptoms.
Tissue Tech are here trialling their single-use T4O pads, and hoping that demodex counts are reduced to zero with minimal or no irritation.
In 2008 Rosacea News highlighted the dubious claims that OcuSoft Lid Scrubs were able to kill demodex mites.
T4O is Less Irritating
We are told in the detailed description that preclinical safety trials have verified that T4O is less irritating compared to raw tea tree oil.
The primary outcome of the trial considers a success to be zero mites after 4 months of use.
Secondary outcomes include a change in the eye lid margin redness and reduction in conjuctival swelling.
Clinical Trial NCT01647217: Demodex Blepharitis Treatment Study (DBTS)
Safety and Efficacy of Single-use Terpinen-4-ol Pads for Treating Ocular Mites A Randomized Clinical Trial
Sponsor: Tissue Tech Inc.
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).
- Arm 1: Experimental: Terpinen-4-ol Treatment Arm45 patients will be randomized into the Study Group and will be subdivided into 3 subgroups (15 patients each) according to the treatment regimen. Changes in the mite counts will be correlated with changes in symptoms and signs. [Terpinen-4-ol Lid scrub once or twice per day for one month.]
- Arm 2: Placebo Comparator: Placebo Pads Control Arm15 patients will be randomized into the control group and will be treated with placebo pads. Changes in the mite counts will be correlated with changes in symptoms and signs. [Placebo Lid scrub once or twice per day for one month].
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.
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