Conditions: Chronic Blepharitis
Keywords: Blepharitis Demodex Mites Tea Tree oil Terpinen
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 17
Healthy volunteers: no

Brief 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).

Detailed description:
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.

Arms:
arm 1: 8 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (3 / 5 patients) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs. arm 2: 9 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 / 4 patients) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs.

Interventions: intervention 1: Terpinen-4-ol intervention 2: Placebo
Intervention descriptions: intervention 1: Lid scrub once or twice per day for one month. intervention 2: Lid scrub once or twice per day for one month

Protocol document: