Demodex Blepharitis Treatment Study (DBTS)
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of Single-use Terpinen-4-ol Pads for Treating Ocular Mites A Randomized Clinical Trial|
- Eradication of Demodex Mites [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Reduction in mites count after treatment compared to the baseline data. If the mites' count remains zero during the last two visits, it is considered "complete eradication". Patients without achieving complete eradication will be categorized as "incomplete eradication".
- Change in Lid Margin redness and Bulbar Conjunctival Hyperemia [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
Lid margin redness and bulbar conjunctival hyperemia will be assessed using an ordered categorical value ranging from 0 (None) to 3 (Severe). Hyperemia will be graded on the following scale and half scores are acceptable:
- None (0) = normal
- Mild (1) = Slight localized injection
- Moderate (2) = pink color
- Severe (3) = dark redness
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Terpinen-4-ol Treatment Arm
45 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.
Lid scrub once or twice per day for one month.
Other Name: T4O
Placebo Comparator: Placepo Pads Contol Arm
15 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.
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.
|Contact: Hosam El Sheha, MD, PhDfirstname.lastname@example.org|
|United States, Florida|
|Ocular Surface Center||Not yet recruiting|
|Miami, Florida, United States, 33173|
|Contact: Hosam El Sheha, MD, PhD|
|Principal Investigator: Scheffer CG Tseng, MD, PhD|
|Sub-Investigator: Hosam El Sheha, MD, PhD|
|Study Chair:||Scheffer CG Tseng, MD, PhD||Tissue Tech Inc.|