title: A Randomized, Controlled Treatment Trial of Eyelid-Warming Therapies in Meibomian Gland Dysfunction.
abstract: OBJECTIVE
  The main treatment for meibomian gland dysfunction (MGD), a major cause of dry eye, is eyelid warming. Lack of compliance is the main reason for treatment failure. This has led to the development of eyelid-warming devices that are safe, effective and convenient. To obtain robust evidence demonstrating their efficacy, the authors conducted a 3-arm randomized clinical study.
  
  
  METHODS
  The authors conducted a 3-month assessor-blinded, randomized, controlled trial of patients from the Singapore National Eye Centre experiencing at least one of eight dry eye symptoms 'often' or 'all the time'. Patients who wore contact lenses, had an active infection or known diagnosis of thyroid dysfunction and rheumatoid arthritis were excluded from the study. MGD participants were randomly assigned to warm towel (n = 25), EyeGiene(®) (Eyedetec Medical Inc., Danville, CA, USA) (n = 25) and Blephasteam(®) (Spectrum Thea Pharmaceuticals LTD, Macclesfield, UK) (n = 25) treatments. The primary efficacy and safety outcomes included the proportions of participants with improved symptoms and changes in best corrected visual acuity (BCVA), respectively. Other outcomes included tear break up time (TBUT), Schirmer test, corneal fluorescein dye staining and number of visibly occluded meibomian gland (MG) orifices.
  
  
  RESULTS
  The study population was 53.5 ± 11.1 years old and predominantly Chinese. For severity of symptom after 3 months of treatment, 78.3% Blephasteam(®) participants reported improvement compared to 45.5% warm towel participants (p = 0.023). The corresponding proportions for improvement in the frequency of symptoms were 82.6% and 50.0%, respectively (p = 0.020). The proportions of improvement of symptoms in EyeGiene(®) patients were not significantly different from warm towel intervention. At 1 month of treatment, the crude odds ratio of improvement of severity of irritation for Blephasteam(®) compared to control was 3.0 (95% CI 0.88-10.18). However, the odds ratio adjusted by age was 5.67 (1.30-24.66). The lid-warming treatments did not significantly change the TBUT, Schirmer test results or number of visibly occluded MGs in the study period. All treatment modalities did not worsen BCVA after 3 months.
  
  
  CONCLUSIONS
  Blephasteam(®) is more effective than warm towel for MGD treatment, with warm towel and EyeGiene(®) being comparable effective. Older age might predict for treatment efficacy. All studied therapies were safe for visual acuity (VA) for 3 months of treatment.
authors.affiliation: Duke-National University of Singapore Graduate Medical School, Singapore, Singapore.
authors.forename: Hui Shan
authors.initials: HS
authors.lastname: Sim
authors.affiliation: Singapore Eye Research Institute, Singapore, Singapore.
authors.forename: Andrea
authors.initials: A
authors.lastname: Petznick
authors.affiliation: Duke-National University of Singapore Graduate Medical School, Singapore, Singapore.
authors.forename: Sylvaine
authors.initials: S
authors.lastname: Barbier
authors.affiliation: Ngee Ann Polytechnic, Singapore, Singapore.
authors.forename: Jen Hong
authors.initials: JH
authors.lastname: Tan
authors.affiliation: Ngee Ann Polytechnic, Singapore, Singapore.
authors.forename: U Rajendra
authors.initials: UR
authors.lastname: Acharya
authors.affiliation: Singapore Eye Research Institute, Singapore, Singapore. sharon.yeo.w.j@seri.com.sg.
authors.forename: Sharon
authors.initials: S
authors.lastname: Yeo
authors.affiliation: Duke-National University of Singapore Graduate Medical School, Singapore, Singapore.|Singapore Eye Research Institute, Singapore, Singapore.|Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.|Singapore National Eye Center, 11 Third Hospital Avenue, Singapore, 168751, Singapore.
authors.forename: Louis
authors.initials: L
authors.lastname: Tong
keywords: Blephasteam®; Clinical study; Dry eye; EyeGiene®; Human; Longitudinal study; Meibomian gland dysfunction; Ophthalmology; Randomized controlled trial; Warm compress