None listed
Conditions
Brief summary
Migraine symptoms overlap with those of ocular surface disease. We hypothesise that by treating dry eye disease, and hence reducing neuroinflammation, and the stress stimulus to corneal nerves, that we can reduce the severity and frequency of migraines in migraine sufferers. Treatment for dry eye disease with topical lubricant eye drops is likely to be preferable to existing therapies for migraine as the side effect profile is minimal. This study will randomly allocate people with migraines to either Systane Hydration eye drops (test) or saline eye drops (control), each to be used as one eye drop to each eye, four times a day for four weeks. At four weeks, participants will be evaluated for their migraine severity and frequency and swapped over to the alternate eye drop for a further four weeks, followed by a final visit.
Interventions
This study is a prospective, randomized, double-masked, cross-over, placebo-controlled, clinical trial in which patients with migraine AND an dry eye questionnaire OSDI score of >13 or a DEQ-5 score of >6 will be invited to participate. Participants will attend three visits. Participants will receive 4 weeks of Systane Hydration and 4 weeks of comparator, separated by a 2-week washout period. Each eye drop will need to be instilled by the participant 4 times a day (one drop per eye each time). B
This study is a prospective, randomized, double-masked, cross-over, placebo-controlled, clinical trial in which patients with migraine AND an dry eye questionnaire OSDI score of >13 or a DEQ-5 score of >6 will be invited to participate. Participants will attend three visits. Participants will receive 4 weeks of Systane Hydration and 4 weeks of comparator, separated by a 2-week washout period. Each eye drop will need to be instilled by the participant 4 times a day (one drop per eye each time). Both Systane Hydration and saline are available over-the-counter. Compliance will be monitored with a diary and with the return of the eye drops.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
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
• Patients with either episodic or chronic migraine. Episodic migraine: < 15 headache days per month for > 3 months; Chronic Migraine (> or equal to 15 headache days per month for > 3 months, where > or equal to 8 are migraine) • Patients with dry eye disease: OSDI > 12 OR DEQ-5 >6 AND at least one of the following signs: Non-invasive keratography break-up time (NIKBUT) < 10, the presence of corneal or conjunctival staining, or osmolarity values > 308 mOsm/L or > 8mOsm/L difference between eyes • All prescription meds for headache have been used consistently for at least 2 months prior to the study. A condition of study participation is that patients do not change their systemic medication regime for the study duration. They will be asked to cease ocular lubricant use at Visit 1, and to return to that for the two-week washout period only.
Exclusion criteria
• Previous refractive surgery • Previous corneal ulceration or ocular infection with Herpes Viruses • Current or previous history of B12 deficiency • Diabetes • Multiple Sclerosis • Chemotherapy • Exclude those on daily topical eye drops • Contact lens wear
Outcome results
None listed