Comparison of Efficacy and Safety of Two Tea Tree Oil-Based Formulations in Patients with Chronic Blepharitis: A Double-Blinded Randomized Clinical Trial
Sule Berk Ergun, MD (1), Gulistan Sanem Saribas, PhD (2), Sait Yarayici, MD (3), Zubeyir Elmazoglu, MSc (3), Aziz Cardak, MD (1), Candan Ozogul, PhD (4), Mustafa Necmi Ilhan, MD, PhD, PhD (5), Cimen Karasu, PhD (3), Ozlem Evren Kemer, MD (6)
1 Department of Ophthalmology, Ankara Numune Training and Research Hospital, Ankara, Turkey,
2 Department of Histology and Embryology, Ahi Evran University Faculty of Medicine, Kırşehir, Turkey,
3 Department of Medical Pharmacology, Gazi University Faculty of Medicine, Ankara, Turkey,
4 Department of Histology and Embryology, University of Kyrenia Faculty of Medicine, Kyrenia, Turkish Republic of Northern Cyprus,
5 Department of Public Health, Gazi University Faculty of Medicine, Ankara, Turkey,
6 Department of Ophthalmology, Health Science University, Numune Health Practice and Research Center, Ankara, Turkey
ABSTRACT
Introduction: It was aimed to evaluate the efficacy of two tea tree oil (TTO)-based cleansing gels in chronic
blepharitis patients.
Methods: Group-1 (basic gel containing 3%(w/w)-TTO) included 50 eyes of 25 patients and group-2 (advanced
gel containing 3%(w/w)-TTO plus essential oils and vitamins) included 48 eyes of 24 patients. Ocular Surface
Disease Index (OSDI), tear breakup time (TBUT), ocular surface staining pattern, Schirmer’s test, impression
cytology, Demodex presence and TNF-α, IL-6, IL-1β levels were evaluated at the first visit and 1 month after
treatment.
Results: In both groups, the mean OSDI score decreased (p1:0.001, p2:0.001), TBUT increased (p1:0.002,
p2:0.004). In group-1, Demodex presence decreased from 42% to 27.8%; in group-2 from 54.2% to 20.6%
(p1:0.302, p2:0.004). IL-1β and IL-6 decreased in group-2 (p1:0.002, p2:0.050). TNF-α decreased in both groups
(p1:0.001, p2:0.001).
Conclusion: Both formulations improved ocular surface parameters. Group 2 showed more reduction in tear
cytokines and Demodex count.
Keywords: Blefar-ex Plus, blepharitis, cleansing gel, demodex, essential oils, tea tree oil
