None listed
Conditions
Brief summary
Nasal neurostimulation has been demonstrated to be a safe and effective method for increasing tear flow in individuals with dry eye due to decreased lacrimal gland function. The aim of this study is to determine whether nasal neurostimulation can increase the number of hours or wear and/or the number of hours of comfortable wear, with decreased dependency on artificial tear supplementation.
Interventions
An intranasal lacrimal neurostimulator is a device (based on a standard TENS machine) used to deliver tiny electrical currents to the inner cavity of the nose, gently activating the nerves. Participants are instructed to place the tips of the device into both nostrils simultaneously. Nasoneurostimulation intensity is applied and controlled by pressing the plus (+) or minus (-) buttons on the device. Neurostimulation is applied for up to three minutes, until it can be felt that the eyes are watering and welling up (reflex tearing). The location of neurostimulation can be controlled by the depth and angle of insertion until a“tickle” sensation is experienced. Neurostimulation can be ceased by pressing the minus button on the device or by withdrawing the device from the nostrils. The device is applied 4 times daily (early morning, around lunchtime, late afternoon and before retiring to bed). This will occur for 5 consecutive days in week 1 or week 2 of the trial (Monday to Friday). The intervening two days (of the weekend) will serve as a wash-out period, during which contact lenses are not worn and the device is not applied. Adherence is monitored via text or email submissions daily from the participants.
Sponsors
Study design
Eligibility
Inclusion criteria
Contact lens wearers reporting end of day discomfort with regular soft contact lens wear
Exclusion criteria
Non soft contact lens wearers Contact lens wearers unwilling to wear a fresh pair of lenses at the start of each week Evidence or history of ocular trauma, infection or surgery Use of systemic medication that has altered in previous 3 months Participation in a clinical trial within 3 months of current trial start date Use of topical medications other than lubricant use for dry eye discomfort