None listed
Conditions
Brief summary
Dry Eye Disease (DED) is a widespread condition that causes discomfort, blurry vision, and a reduced quality of life. Current treatments, such as artificial tears and warm compresses, are often inconvenient to apply, result in plastics waste that raises sustainability concerns - both in space and on Earth. This study will test a new, non-invasive external nasal neurostimulation device, which stimulates the nerves around the nose to help the eyes produce more natural tears. Researchers will compare its effectiveness to a sham therapy (which does not provide real stimulation) to see if it improves tear quality and eye comfort. Participants will be randomly assigned to one of two groups: one using the external nasal neurostimulation device correctly and the other using the device over a non-stimulatory area. Researchers will measure tear quality at three time points - before treatment, 30 minutes after treatment, and 5 hours post-treatment. The main goal is to see if the device improves the tear film’s protective oily layer, which is essential for preventing dry eye symptoms. By exploring a reusable, drug-free alternative, this study aims to advance dry eye treatment for both space missions and everyday use on Earth.
Interventions
Participants will be instructed on the correct (active) use of the external nasal neurostimulator (iTear100, Olympic Ophthalmics, Issaquah, WA). Under supervision, participants will apply the tip of the device, which delivers high frequency vibrations, externally for 30 seconds, touching the skin on each side of the nose, at the site of the external nasal nerve, on a single occasion. Tear film and ocular surface signs are assessed at baseline, 30 minutes post-treatment, and at 5 hours post-appli
Participants will be instructed on the correct (active) use of the external nasal neurostimulator (iTear100, Olympic Ophthalmics, Issaquah, WA). Under supervision, participants will apply the tip of the device, which delivers high frequency vibrations, externally for 30 seconds, touching the skin on each side of the nose, at the site of the external nasal nerve, on a single occasion. Tear film and ocular surface signs are assessed at baseline, 30 minutes post-treatment, and at 5 hours post-application.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Aged 18 years or older, able and willing to comply with study instructions • Self-reported dry eye symptoms • Normal lid architecture, and closure • Dry eye diagnosis according to the Tear Film & Ocular Surface Society's third Dry Eye Workshop (TFOS DEWS III) diagnostic criteria (Symptoms: OSDI-6 equal or greater than 4. Signs: 1 positive finding of non-invasive Keratograph breakup time (NIKBUT) (less than 10 s) / osmolarity (equal or greater than 308mOsm/L or interocular difference of greater than 8mOsm/L) / staining (greater than 5 corneal spots, 9 conjunctival spots; or lid wiper epitheliopathy of equal or greater than 2mm length and equal or greater than 25% lid margin width) • Evidence of lipid layer grade equal or less than 3
Exclusion criteria
• Contact lens wear within 24 hours of the baseline visit, or planned during the course of the study • Lubricating eye drop application within 12 hours of the baseline visit, or planned during the course of the study • History of systemic conditions that would be expected to interfere with interpretation of the study results, such as autoimmune disease or current pregnancy. • Ocular surgery (including refractive or cataract surgery) or dermatological surgery within 3 months of study participation • History or presence of any ocular disorder or condition in either eye that would likely interfere with the interpretation of the study results. This includes significant corneal or conjunctival scarring, pterygium or nodular pinguecula, current ocular infection or inflammation unrelated to dry eye
Outcome results
None listed