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Exploring nasal neurostimulation for managing contact lens discomfort

Exploring the potential of nasal neurostimulation to manage contact lens discomfort

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000745549
Enrollment
30
Registered
2015-07-20
Start date
2015-07-23
Completion date
2015-10-16
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 wat

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

Associate Professor Jennifer P. Craig
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026