Patients in Australia and New Zealand will participate in a clinical trial which will study a device intended to treat the condition of dry eye without use of surgery or drugs.
The purpose of the study is to demonstrate that lacrimal gland neurostimulation increases tear production and improves symptoms of dry eye disease over baseline measurements.
The randomised, masked controlled trial will include approximately 60 patients suffering from moderate to severe dry eye disease and will take place over three months. Patients will self-administer treatment four times a day and undergo six ophthalmic examinations over the study period.
Primary outcomes will be the mean Schirmer test score compared to baseline, with the secondary outcome the mean ocular surface disease index score compared to baseline. An addition secondary outcome will be the mean dry eye symptoms as assessed by a visual analogue scale compared to baseline.
The study, ‘Stimulation Therapy to Produce Tears for the Treatment of Dry Eye’, is being conducted by Californian based Oculeve Inc.