Demodex Blepharitis Treatment Study (DBTS)
|ClinicalTrials.gov Identifier: NCT01647217|
Recruitment Status : Completed
First Posted : July 23, 2012
Results First Posted : July 26, 2017
Last Update Posted : July 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Blepharitis||Drug: Terpinen-4-ol Other: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Safety and Efficacy of Single-use Terpinen-4-ol Pads for Treating Ocular Mites A Randomized Clinical Trial|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||July 2015|
Experimental: Terpinen-4-ol Treatment Arm
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.
Lid scrub once or twice per day for one month.
Other Name: T4O
Placebo Comparator: Placepo Pads Contol Arm
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.
Lid scrub once or twice per day for one month
- Change in the Number of Demodex Mites [ Time Frame: 6 weeks ]Change 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 6 weeks ]Lid margin redness and bulbar conjunctival hyperemia were each assessed using an ordered categorical value ranging from 0 (None) to 3 (Severe). The two scores were summed to obtain the final score, which ranges from 0 (None) to 6 (Severe).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647217
|United States, Florida|
|Ocular Surface Center|
|Miami, Florida, United States, 33173|
|Study Chair:||Scheffer CG Tseng, MD, PhD||Tissue Tech Inc.|