CLINICAL TRIAL FOR EVALUATING THE EFFICACY AND SAFETY OF
BLEFAR-EX PLUS CLEANSING GEL IN CHRONIC BLEPHARITIS PATIENTS
Eye burning/dryness, dandruff on eyelashes, itchy eyelids and inflammation are the symptoms of “Blepharitis”, “Demodex folliculorum” infestation in eyelids plays an important role in the pathogenesis and cleansing/hygiene is essential for the success of the treatment. This randomized/double-blind clinical research aimed to carry out the efficacy and safety studies of cleansing gels as PRODUCT-1 including only 3% TTO as bioactive substance in its formulation and PRODUCT-2 (Blefar-ex Plus) containing 3% TTO and Calendula-oil/Borage-oil / Bilberry Extract / Vitamin-E/Vitamin-B5.
Research was started by the approval of Ministry of Health-Turkish Medicines/Medical Devices Agency (01.07.2016 date/no 86341) in Ankara Numune Education and Research Hospital, and the patients who are first time diagnosed with “Blepharitis” (n=50; Age:34-63; Female/Male) were randomized into two groups (PRODUCT/GROUP-1; PRODUCT/GROUP-2) and they were examined by the ophthalmologist in the initially and then 30 days after starting to use each PRODUCT. The subjective complaints, objective examination findings, histological analyze and inflammatory markers were evaluated. Wilcoxon rank-sum / Mann-Whitney U / McNemar tests were performed to analyze the measurements before and after applications (SPSS/version 21.0/SPSS/Inc).
Both PRODUCTs decreased Ocular Surface Disease Index (OSDI) (P<0.001) and increased Tear Film Breakup Time (TBUT) (P<0.002). Oxford-Scale-Scores and Schirmer did not change after using the PRODUCTs (P>0.05). PRODUCT-1 did not affect demodex count but PRODUCT-2 showed remission (P<0.004). Impression cytology to conjunctival surface (PAS / haematoxylin) displayed increased number of goblet cells with regular epithelial cells by PRODUCT-2 (NELSON Score). PRODUCT-2 inhibited IL-1β (P<0.002) and IL-6 (P<0.05) in tears. TNF-α was also diminished by both PRODUCT (P<0.001).
Blefar-ex Plus is effective in reducing mucinous cell damage, eliminating dry eye symptoms, increasing tear quality, preventing ocular irritation and inflammation, maintaining epithelial integrity, and demodex eradication compared to PRODUCT-1. PRODUCTS containing 3% TTO did not have the reported adverse effects for existing cosmetics containing ≥ 5% TTO. Especially PRODUCT-2 (Blefar-ex Plus) can be recommended and safely used for cleansing purpose of eyelash, eyelid and surroundings in Blepharitis patients.