Efficacy and safety evaluation of three medicated eye patches in Demodex blepharitis: a multicenter, double-blind, randomized controlled clinical trial

Authors: Wang Shasha,  Jiang Yan,  Huang Jie,  Yang Zhen,  Long Junjun,  Fei Xinfeng,  Liu Yan,  Li Ying,  Li Lan,  Chen Jili
DOI: 10.3760/cma.j.cn115989-20230407-00121
Published 2023-05-10
Cite as Chin J Exp Ophthalmol, 2023, 41(5): 450-456.

Abstract                              [Download PDF] [Read Full Text]

Objective

To evaluate and compare the clinical efficacy and safety of three different medicated eye patches in the treatment of Demodex blepharitis.

Methods

A multicenter, randomized, double-blind, parallel-controlled clinical trial was conducted.A total of 140 patients (280 eyes) with Demodex blepharitis were recruited in Shanghai Jing’an District Shibei Hospital, Xi’an Fourth Hospital and Kunming First People’s Hospital from July 2021 to December 2022.The affected eyes were randomly divided into tea tree oil group, okra oil group, basal fluid control group and metronidazole group by the random number table method.Eye patches containing 20% tea tree oil, 1% okra oil, prepared base solution and 2% metronidazole were applied to the eyes for 28 days by the double-blind method.The count of Demodex was evaluated before treatment and on days 14 and 28 of treatment.Ocular surface symptoms were scored according to Ocular Surface Disease Index (OSDI). The degree of congestion at the eyelid margin and cylindrical dandruff at the root of eyelashes were scored under a slit lamp microscope.The effective rate was calculated according to the comprehensive scores above, and the adverse reactions of the subjects were observed.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Shanghai Jing’an District Shibei Hospital (No.YL-20200320-05). All the subjects were informed of the significance, purpose and method of the study.Written informed consent was obtained from each subject before any medical examination.

Results

All subjects completed the treatment and follow-up, and the loss to follow-up rate was 0%.After 14 and 28 days of treatment, the Demodex count was significantly decreased in all groups compared with before treatment (all at P<0.05). After 28 days of treatment, the number of Demodex in tea tree oil group, okra oil group and metronidazole group were significantly lower than that in basal fluid control group, with statistically significant differences (all at P<0.05). The OSDI score, palpebral margin congestion score and cylindrical dandruff score on 14 and 28 days after treatment in tea tree oil group, okra oil group and metronidazole group were significantly lower than before treatment, showing statistically significant differences (all at P<0.05). After 28 days of treatment, the effective rates of tea tree oil group, okra oil group and metronidazole group were 71.4%, 71.4% and 62.9%, respectively, which were significantly higher than 25.7% in basal solution control group.No serious local or systemic adverse reactions were found during the treatment and follow-up.

Conclusions

Eye patches containing tea tree oil, okra oil and metronidazole have significant effects on the treatment of Demodex blepharitis, which can improve the biological environment of the palpebral margin and eliminate the inflammation related to blepharitis.

Key words:

Blepharitis; Demodex; Outcomes; Safety; Multi-center randomized controlled clinical trail; Medicated eye patches

Contributor Information

Wang Shasha

Department of Ophthalmology, Shanghai Jing’an District Shibei Hospital, Shanghai 200443, China

Jiang Yan

Department of Ophthalmology, Shanghai Jing’an District Shibei Hospital, Shanghai 200443, China

Huang Jie

Department of Ophthalmology, Shanghai Baoshan District Integrated Traditional Chinese and Western Medicine Hospital, Shanghai 201999, China

Yang Zhen

Department of Ophthalmology, The Fourth Hospital of Xi’an City, Xi’an 710005, China

Long Junjun

Department of Ophthalmology, The First People’s Hospital of Kunming, Kunming 650200, China

Fei Xinfeng

Department of Ophthalmology, The Fourth People’s Hospital of Shanghai, Shanghai 200081, China

Liu Yan

Department of Ophthalmology, The First People’s Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200080, China

Li Ying

Department of Ophthalmology, The Fourth Hospital of Xi’an City, Xi’an 710005, China

Li Lan

Department of Ophthalmology, The First People’s Hospital of Kunming, Kunming 650200, China

Chen Jili

Department of Ophthalmology, Shanghai Jing’an District Shibei Hospital, Shanghai 200443, China

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