Antimicrobial and clinical efficacy of Cliradex as compared with I-Lid 'n Lash® hygiene in treating blepharitis: A randomized, outcomes-assessor masked, clinical trial
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Authors: Yufeng Chen, Reginald Tan, Mohammed Taha, Pablo
Morales, Kashif Baig, George Mintsioulis, Setareh Ziai
Author Disclosure Block: Y. Chen: None. R. Tan: None. M.
Taha: None. P. Morales: None. K. Baig: None. G.
Mintsioulis: None. S. Ziai: None.
Abstract Body:
Purpose: To assess the efficacy of tea tree oil eyelid wipe
in the treatment of blepharitis
Study Design: Prospective, randomized control study
Methods: Twelve blepharitis patients with more than 3 months of
symptoms presenting to the Ottawa Hospital, who were not on any steroids,
antibiotics, or other preserved eye drops were enrolled in the study. An
institutional review ethics board approval was obtained. At the initial visit,
a culture of the patient’s lid margin was done on blood and chocolate agar to
assess how much eyelid bacteria was present at baseline. Objective measurements
such as visual acuity, grading of lid margin inflammation and conjunctival
inflammation were taken. Patients were also asked to fill out a survey grading
the symptoms they experienced secondary to the blepharitis. Patients were then
randomized, with concealment, to receive either eye wipes with or without tea
tree oil for 2 weeks. After using the wipes for 2 weeks, all of them were asked
to discontinue the wipes and come back for a 2 week, 4 week and 6 week
follow-up. At each follow up, culture of the lid margin, vision, lid margin
inflammation grading, conjunctival inflammation grading, and grading of
symptoms were taken.
Results: Patients randomized to the tea tree oil wipes had a
baseline CFU count of 43.3 (blood agar[B])/11.8 (chocolate agar[C]) at
baseline, 7.4 (B)/2.8 (C) at 2 weeks, 48.3 (B)/5.3 (C) at 4 weeks, and 83.8
(B)/4.5 (C) at 6 weeks. Patients randomized to the non-tea tree oil wipes had a
CFU count of 25.7 (B)/14(C) at baseline, 44 (B)/3.3(C) at 2 weeks, 40 (B)/6(C)
at 4 weeks, and 22 (B)/3(C) at 6 weeks. There was no significant change in CFU
compared to baseline on blood agar at 2 weeks between the tea tree oil and
non-tea tree oil group (-25 versus +18.3, p=0.21), 4 weeks (+43.7 versus +39,
p=0.91), or 6 weeks (+55.3 versus +11.2, p=0.18). Change in vision was not
significantly different between the two groups at 2 weeks (p=0.3), 4 weeks
(p=1), or 6 weeks (p=0.8). The amount of lid margin inflammation was not
significantly different between the two groups at 2 weeks (p=0.6), 4 weeks
(p=1), or 6 weeks (p=0.07). The amount of conjunctival inflammation was not
significantly different between the two groups at 2 weeks (p=0.9), 4 weeks
(p=1), or 6 weeks (p=0.37). Patients’ subjective grading of symptoms was also
not significantly different at 2 weeks (p=0.9), 4 weeks (p=0.3), or 6 weeks
(p=0.66). Two patients were lost to follow up, and one patient randomized to
the tea tree oil wipe group could not complete the study due to side effects.
Conclusions: Although the trend is that tea tree oil is more
effective at lowering bacterial count immediately after use, this effect does
not last. Though there is initially a more significant decrease in bacterial
load in the tea tree oil group, at all follow ups there was no difference in
the amount of lid/conjunctival inflammation or patients’ subjective reporting
of symptoms. One patient also complained of severe reaction to tea tree oil
wipes.