Tear lipid layer thickness and ocular comfort with a novel device in dry eye patients with or without Sjogren's syndrome

Background: To measure changes in tear-film lipid-layer thickness (LLT) and symptoms in patients with dry eye symptoms with and without Sjogren's syndrome after using a novel device. The device is designed to promote release of meibomian sebum into the tear film by delivering latent heat to the eyelids. Study design: Two prospective, controlled, randomised, observer-masked, single-intervention studies. Methods: Two independent studies were conducted in a major university hospital in the South West of England. The first study involved 24 patients with dry eye symptoms without Sjogren's [the PDE study] and the second study involved 31 patients with dry eye symptoms and Sjogren's syndrome (the SS study). The PDE study was randomised into two groups. Group 1 (12 patients) underwent 10 min of treatment with the activated device and Group 11 (12 patients) had no treatment. The SS study was similarly randomised into Group 1 (17 patients) and Group 11 (14 patients). The LLT and subjective alterations in ocular comfort of each subject were assessed prior and immediately after 5 and 30 min subsequent to the 10-min period. In the SS study, a further assessment was carried out at 60 min. Results: In the PDE study, treated patients exhibited a bilateral increase of LLT at 5 min (right eyes, 1.2 levels, p < 0.0005; left eyes, 1.0 levels, p < 0.0005, Mann-Whitney) and at 30 min (right eyes, 0.7 levels, p < 0.005; left eyes, 0.6 levels, p < 0.005). Mean symptom scores improved in the treated group compared with the control group at 5 min (treatment group, +2.0; control group, +0.2; p < 0.05) and 30 min (treatment group, +2.8; control group, +0.4; p < 0.015). In the SS study, treated patients exhibited a bilateral increase of LILT, 5 min (right eyes, 0.5 levels, p < 0.009; left eyes, 0.5 levels, p<0.005, Monte Carlo 2-tailed), 30 min (right eyes, 0.5 levels, p < 0.007; left eyes 0.5 levels, p < 0.002) and 60 min (right eyes, 0.3 levels, p < 0.1; left eyes, 0.3 levels, p < 0.05). There was no change in any of the control patients in any of the assessments. With regard to symptom scores, the mean change at S min measured +0.8 in the treatment group and remained relatively unchanged at +0.1 in the control group (p < 0.1). At 30 min, this change measured +1.3 in the treatment group and +0.1 in the control group (p < 0.03) and at 60 min, the change measured +1.5 in the treatment group and remained at +0.1 in the control group (p < 0.02). Conclusion: Meibomian therapy with this novel device increases LLT and ocular comfort in patients with dry eye symptoms with and without Sjogren's syndrome.