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Clinical Trial 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).


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01647217
Study type Interventional
Source Tissue Tech Inc.
Contact Hosam El Sheha, MD, PhD
Phone 305-274-1299
Email hoss88@gmail.com
Status Recruiting
Phase Phase 1
Start date February 2014
Completion date April 2015

See also
  Status Clinical Trial Phase
Completed NCT02236403 - Treatment of Demodex Blepharitis With Ivermectin Gel 0.1% Plus Metronidazole 1% Phase 3