Abstract
Purpose: :
Patients with mild, moderate or severe dry eye continue to require multiple therapeutic interventions. Patients with meibomian gland dysfunction (MGD) often suffer from evaporative tear loss, as evidenced by accelerated tear film break up time and increased lactoferrin tear concentration. Nutritional supplementation, particularly, gamma linolenic acid (GLA) and omega 3 fatty acids may improve MGD and secretion contents. In this study, the efficacy of a nutritional supplement containing GLA and omega 3 fatty acids taken daily for 6 months was evaluated for treatment of post-menopausal patients with moderate to severe keratoconjunctivitis sicca.
Methods: :
This randomized, double-blind, placebo-controlled, prospective clinical trial was conducted at two sites with multiple investigators. A total of 36 enrolled subjects were either given nutritional supplements (HydroEye®, ScienceBased Health, Houston, TX, n=17) or placebo (n=19) for a period of 6 months. Subjects were evaluated at baseline, 4, 12 and 24 wks for ocular surface disease index (OSDI) scores, Schirmer test, tear breakup time (TBUT), conjunctival and corneal staining. Conjunctival impression cytologies were also obtained and were stained for HLA-DR and CD11c.
Results: :
After 24 wks, patients reported a significant improvement in irritation symptoms, with an average OSDI score of 34±5 after placebo treatment (n=19) compared to 21±4 after supplement treatment (n=17, p=0.05). After 24 wks placebo treatment, dendritic cell HLA-DR staining increased significantly by 36±9% and integrin staining (CD11c) also increased significantly by 34±7% when compared to supplement treatment (n=19/group, p<0.001). Neither treatment had any effect on tear flow, TBUT, conjunctival or corneal staining.
Conclusions: :
Significant improvement in self reported patient assessments as well as inflammatory biomarkers indicate that nutritional supplementation over time improves the signs and symptoms of evaporative dry eye and thereby MGD. In this study, a specifically formulated oral nutritional preparation for the treatment of dry eye was shown to be beneficial, particularly in patients with imbalanced diets.
Clinical Trial: :
http://www.clinicaltrials.gov NCT00883649
Keywords: nutritional factors • cornea: tears/tear film/dry eye