None listed
Conditions
Brief summary
The aim is to determine if SYSTANE® PRO preservative-free lubricating eye drops are non-inferior to Thealoz® Duo preservative-free lubricating eye drops in alleviating symptoms of dry eye. This will be established in a prospective randomised controlled crossover study. Participants will apply one drop type 4 times a day for a period of 4 weeks, then apply the other drop 4 times a day for 4 weeks. The order in which the two drops are applied will be randomised and is concealed from participants and investigators until after the study is completed.
Interventions
Participants apply SYSTANE® PRO preservative-free eye drops, 1-2 drops, 4 times a day for 4 weeks. Ocular surface symptoms and signs are collected at baseline and after 4 weeks.
After 4 weeks participants crossover to apply Thealoz® Duo preservative-free eye drops, 1-2 drops, 4 times a day for a further 4 weeks after which time ocular surface symptoms and signs are again collected. There is no washout period in between.
Participant diaries are used, throughout, to record compliance, and for eac
Participants apply SYSTANE® PRO preservative-free eye drops, 1-2 drops, 4 times a day for 4 weeks. Ocular surface symptoms and signs are collected at baseline and after 4 weeks. After 4 weeks participants crossover to apply Thealoz® Duo preservative-free eye drops, 1-2 drops, 4 times a day for a further 4 weeks after which time ocular surface symptoms and signs are again collected. There is no washout period in between. Participant diaries are used, throughout, to record compliance, and for each product, bottles are collected after 4 weeks' use and weights compared, pre and post-study, as a further measure of compliance.
Sponsors
The University of Auckland
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
• Age equal to or greater than 18 years • Minimum of 6 months history of self-reported dry eye • Dry eye diagnosis according to the Tear Film and Ocular Surface Society Dry Eye Workshop III (TFOS DEWS III) diagnostic criteria (6-item Ocular Surface Disease Index (OSDI-6) score of greater or equal to 4 plus any one or more of the following signs: Non-invasive tear breakup time (NIBUT) less than 10 seconds, hyperomsomolarity of greater than or equal to 308mOsm/L or an interocular difference in osmolarity of greater than 8 mOsm/L; corneal fluorescein staining of more than 5 corneal spots, conjunctival lissamine green staining of more than 9 conjunctival spots, or lid wiper epitheliopathy of greater than or equal to 2mm in length and greater than or equal to 25% sagittal width)
Exclusion criteria
• Non-normal lid architecture affecting lid closure/blink • Anaesthetic cornea • Active ocular allergies or history of frequent ocular allergies • Severe dry eye disease not manageable with only topical lubricating drops • Unwillingness to restrict topical eye drop use to only the study tear supplement • Patients who are using other ophthalmological drops of any kind • Contact lens wear within 1 week of study commencement or during the study • Warm compress therapy, unless stable for at least 3 months prior to study enrolment and maintained at the same frequency throughout the trial • History of in-office therapies for dry eye disease (DED) such as thermal pulsation or light therapy in the last 12 months • History of ocular surgery (such as refractive or cataract surgery) in either eye within 6 months of the screening visit • Reduced visual acuity (less than or equal to 20/200), significant corneal or conjunctival scarring, pterygium or nodular pinguecula; current ocular infection or inflammation unrelated to dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration • A systemic condition or disease considered unstable or judged by the investigator to be incompatible with participation in the study (including but not limited to current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease), pregnancy
Outcome results
None listed