None listed
Conditions
Brief summary
Background: Contact lenses (CLs) are a popular choice for correcting refractive error, offering freedom from spectacles and improving quality of life for wearers but they destabilise the tear film overlying the ocular surface, risking ocular surface desiccation and discomfort symptoms for the wearer. Topical artificial tear supplements are the recommended treatment for patients with dryness symptoms, with or without CLs, and are available in a range of modalities, with and without lipid components. The behaviour of the eyedrops in the presence of a CL differs from that in the non-CL wearing eye but has been poorly characterised. Understanding the interactions between CLs and different drop modalities is critical to ensuring patients are offered sound, evidence-based advice. This study seeks to address the gap in knowledge by evaluating the impact of drop modalities with and without lipid components on tear film stability both in the presence of CL wear and without. Objectives: To evaluate the relative short-term effects on the pre-ocular and pre-lens tear film quantity and quality (its non-invasive tear film break-up time, tear meniscus height, lipid layer grade, lipid layer thickness and tear evaporation rate) following application of lubricating eye drops or eye spray. Study Design: Prospective, randomised, investigator-masked, controlled clinical trial (for n=38 participants with or without symptoms of dry eye. Study hypothesis: The lipid layer grade will be higher with instillation of a lipid drop than an aqueous drop, following application of a contact lens.
Interventions
Brief name: Topically applied tear film supplements
Dose administered: A masked investigator would administer one drop/spray applied as a single application to each eye, on the day of examination 10 minutes before contact lenses are worn. Each participant will be tested for all of the interventions with one intervention randomly assigned per visit for a total of 3 intervention visits and 1 control visit. On each visit the participants will be asked to wear CL for no more than 30 minutes. The C
Brief name: Topically applied tear film supplements Dose administered: A masked investigator would administer one drop/spray applied as a single application to each eye, on the day of examination 10 minutes before contact lenses are worn. Each participant will be tested for all of the interventions with one intervention randomly assigned per visit for a total of 3 intervention visits and 1 control visit. On each visit the participants will be asked to wear CL for no more than 30 minutes. The CL lenses will be discarded at end of each visit. All the interventions used in this study are over-the-counter products commercially available in New Zealand and include two types of lubricating eye drops (Systane Ultra and Systane Complete, Alcon), one type of lubricating eye spray (Tears Again, Eye Spray, BioRevive) and one type of soft daily disposable silicone hydrogel contact lens (MyDay, Cooper Vision). All test visits will be scheduled within 2 weeks from enrollment and there will be a minimum washout period of 24 hours between the test visits.
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
Yes
Inclusion criteria
- 18 years or older - Habitual soft CL wearer (of at least 1 month prior to study enrolment) - Willing and able to follow the protocol accurately and to attend four study visits within a two week period - Willing to not wear CL or apply any eye drops within 12 hours of the test visits
Exclusion criteria
- Active ocular allergies - Ocular surgery or dermatological treatments in the previous three months or planned during the study period - Current or planned pregnancy or lactation during the study - History of major systemic or ocular conditions
Outcome results
None listed