None listed
Conditions
Brief summary
To establish the impact of different topical dry eye therapies on tear film characteristics, at 4 separate clinical visits (separated by a minimum of 48 hours), participants will each receive, in a randomised order, 1 drop of Alcon SYSTANE® Complete preservative-free eye drops instilled in each eye, or 1 drop of Novaliq Gmbh NovaTears® in each eye or 1 spray of BioRevive Tears Again® liposomal spray to each closed eye, or 1 drop of Alcon SYSTANE® Ultra preservative-free eye drops instilled in each eye. All participants will receive all products in this crossover study design, but the order of application will be randomised according to a computer-generated randomisation schedule that is concealed from the investigator until the time of product application. Ocular surface symptoms and signs are collected at baseline and at 15 minutes, 2 hours, 4 hours and 6 hours after product instillation by a masked investigator, who is blinded to the product applied. It is hypothesised that the lipomimetic study drops will be superior to non-lipomimetic comparator drops in improving tear film quality.
Interventions
In a crossover manner (all participants will receive all interventions across the course of the study), participants will be randomised to receive, on Day 1, either:
Application of 1 drop of SYSTANE® Complete (Alcon) preservative-free eye drops to each eye by the clinical investigator
OR
Application of 1 drop of NovaTears® (Novaliq GmbH) eye drops in each eye by the clinical investigator
OR
Application of 1 spray of BioRevive Tears Again® (Optima Pharmazeutische GmbH) liposomal spray to each c
In a crossover manner (all participants will receive all interventions across the course of the study), participants will be randomised to receive, on Day 1, either: Application of 1 drop of SYSTANE® Complete (Alcon) preservative-free eye drops to each eye by the clinical investigator OR Application of 1 drop of NovaTears® (Novaliq GmbH) eye drops in each eye by the clinical investigator OR Application of 1 spray of BioRevive Tears Again® (Optima Pharmazeutische GmbH) liposomal spray to each closed eye by the clinical investigator. Over the course of Days 2, 3 and 4, (a minimum of 48 hours apart), participants will receive application of each of the other listed products and the comparator drop, SYSTANE® Ultra (Alcon) preservative-free eye drops, in a randomised order as specified in the predetermined randomisation schedule. All products are applied by a trained clinical investigator, who will complete a session attendance checklist at each visit to confirm adherence to the intervention schedule. Ocular surface symptoms and signs are collected by a masked clinical investigator at baseline, at 15 minutes after product application and 2, 4 and 6 hours after product application on the same day.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age greater than or equal to 18 years • Positive dry eye disease (DED) symptoms (Ocular Surface Disease Index-6 (OSDI-6) score of greater than or equal to 4) • Lipid layer thickness < 72 nm or lipid layer grade less than or equal to 3
Exclusion criteria
• Non-normal lid architecture affecting lid closure/blink • Inability or unwillingness to commit to study visit requirements • Unwillingness or inability to refrain from topical eye drop use, including artificial tear supplements, within 12 hours of the study start and over the course of the study • Unwillingness to be advised of incidental findings • Wear of contact lenses within 12 hours and throughout the days of the study • History or presence of any ocular disorder or condition in either eye other than dry eye that would likely interfere with the interpretation of the study results or patient safety, e.g. eye infection • Active or uncontrolled severe systemic allergy, chronic seasonal allergies, rhinitis, or sinusitis requiring treatment on the study day • Participation in any clinical trial with a new active substance or a new device within 30 days of enrolment
Outcome results
None listed