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Hirotaka Tanabe, Minako Kaido, Motoko Kawashima, Reiko Ishida, Kazuo Tsubota; Safety and efficacy study to evaluate wiping the lid margins with tap water alone or in combination with lid hygiene shampoo in subjects with normal meibomian glands. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3865.
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© ARVO (1962-2015); The Authors (2016-present)
We performed a prospective clinical study to evaluate the safety and efficacy of using tap water alone or in combination with lid hygiene shampoo to wipe lid margins with normal meibomian glands.
Fourteen eyes of 7 subjects (6 males and 1 female aged 28 to 56 years old [40.8 ± 11.4 years old]) with normal meibomian glands were evaluated in the Ophthalmology Department of Keio University Hospital before and after wiping the lid margins using tap water alone at first and then tap water in combination with lid hygiene shampoo (Eye Shampoo [MediProduct, Japan]) one week later. The ethics committee of the Keio University School of Medicine approved the protocol. We used t-tests to analyze the tear break-up time (TBUT) (grades 0 to 10) and Wilcoxon signed-rank tests to analyze corneal and conjunctival fluorescein/lissamine green/rose bengal staining scores (grades 0 to 9), lid margin lissamine green staining scores (grades 0 to 3), subjective symptoms (grades 0 to 100) (as assessed via the visual analog scale [VAS]), and tear lipid layer interference (grades 1 to 5) (as assessed using a DR-1 tear interference camera [Kowa Co., Nagoya, Japan]).
A significant exacerbating change (P<0.05) was not detected after either method was applied in terms of the VAS score, the TBUT, corneal and conjunctival staining, lid margin lissamine green staining, and tear lipid layer interference. For the VAS score, foreign body sensation and eye discharge recognition were significantly improved (P<0.05) only in the group using lid hygiene shampoo (9.71±14.0 to 3.92±9.02, P=0.031; 4.96±5.52 to 1.14±2.28, P=0.022, respectively), and eyestrain was significantly improved only in the group using tap water alone (17.0±15.3 to 1.57±4.01, P=0.008). Although there were no significant differences in the other VAS parameters, certain changes indicating improvements (P<0.1) in the parameters related to stimulation, i.e., pain and smarting pain, were noted only in the group using lid hygiene shampoo (3.64±6.18 to 0.64±1.64, P=0.098; 3.28±5.42 to 0.64±1.73, P=0.098, respectively).
The use of tap water alone or in combination with lid hygiene shampoo to wipe lid margins appears to be safe for maintaining lid hygiene in normal subjects. The efficacy of lid hygiene shampoo seems greater than tap water alone based on the VAS parameters.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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