NCT01647217

Demodex Blepharitis Treatment Study

Safety and Efficacy of Single-use Terpinen-4-ol Pads for Treating Ocular Mites A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: BioTissue Holdings, Inc · Industry
• Sex: All
• Age: 15 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Blepharitis

Interventions

Type	Name	Description
DRUG	Terpinen-4-ol	Lid scrub once or twice per day for one month.
OTHER	Placebo	Lid scrub once or twice per day for one month

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-06-01
• Completion: 2015-07-01
• First posted: 2012-07-23
• Last updated: 2017-07-26
• Results posted: 2017-07-26

Locations

1 site across 1 country: United States