None listed
Conditions
Brief summary
The research questions will be addressed using a small, carefully controlled clinical study administered to adult contact lens wearers. This research aims to find out whether a new contact lens packaging solution improves comfort for people who wear contact lenses compared to the current solution and to two other commercially available contact lenses on the market. The study will explore how comfortable the lenses feel after six hours of wear and whether the new packaging helps reduce the build-up of natural deposits on the lenses. Each participant will try four different types of daily disposable contact lenses over several weeks at UNSW Sydney’s Eye Research Group clinic. Participants will be fitted with each lens type in a randomised order (like flipping a coin). Participants will insert the allocated study lens in the morning on Day 1 and return on the same day after 6 hours of lens wear. Participants will provide feedback on comfort and vision, their eyes will be assessed and the worn contact lenses collected. Participants will then be dispensed with a 7-day supply of that same lens type and asked to wear the lenses during the week and return for follow-up assessment after wearing the lenses for 6 hours at the 7-day follow-up visit. Simple eye tests and questionnaires will be used to collect information, and lenses will be examined after wear to understand how well they stay clean. These methodologies and target populations are appropriate to meet the research aims because the study design allows direct comparison between lenses under real-world conditions. Experienced contact lens users can reliably describe comfort differences and follow the required routines safely. This approach will help determine whether the new packaging solution offers practical improvements for everyday lens wearers.
Interventions
Participants in this clinical trial will receive four different types of daily disposable soft contact lenses, including a modified Miru 1-Day Menicon Flat Pack lens packaged in a new solution and three comparative lenses in their standard solution (Miru 1-Day in the standard solution, Acuvue 1 Day Moist and Proclear 1 Day.). The modified Miru 1day Menicon Flat Pack contact lenses are the same lens as the approved product, but the packaging solution has been modified by adding sodium hyaluronate
Participants in this clinical trial will receive four different types of daily disposable soft contact lenses, including a modified Miru 1-Day Menicon Flat Pack lens packaged in a new solution and three comparative lenses in their standard solution (Miru 1-Day in the standard solution, Acuvue 1 Day Moist and Proclear 1 Day.). The modified Miru 1day Menicon Flat Pack contact lenses are the same lens as the approved product, but the packaging solution has been modified by adding sodium hyaluronate, edetate disodium and cyanocobalamin, as well as slightly increasing the salt concentration (osmolality). Eligible participants will be randomised to wear all four study lens types in this cross-over study. Instructions on the use of lenses will be the same for all lenses. Participants will be instructed to wear the assigned study contact lenses for a minimum of 5 days per week, 6 hours per day, and to present to the Day 7 assessments for each lens type, having worn the study contact lenses for approximately 6 hours that day. All unused study contact lenses will be collected and participants will undergo a washout period of minimum 48 hours to a maximum of 7 days before the next lens pair.
Sponsors
University of New South Wales, Sydney
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
• Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent • 18 years of age or older • Experienced soft contact lens wearer • Mild to moderately short-sighted • Willing to wear the study contact lenses and comply with the study visit schedule • Can achieve binocular contact lens corrected visual acuity of 6/7.5 with the range of study lens powers available • Willing to refrain from wearing habitual contact lenses for 48 hours prior to the scheduled study lens dispense visits • Willing to refrain from instilling any eye drops within 24 hours prior to each study visit and while wearing the study contact lenses • Willing to wear the study contact lenses for a minimum of 5 days per week, 6 hours per day, and to present to each Day 7 assessment having worn the study contact lenses for approximately 6 hours that day.
Exclusion criteria
• Have any active corneal infection, ocular disease or systemic disease that would affect the safe wearing of contact lenses • Use or have a need for any systemic or topical medications which may alter normal ocular findings/are known to affect a participant’s ocular health/physiology either in an adverse manner or risk providing a false positive • Have had eye surgery within 6 months immediately prior to enrolment for this trial • Gas permeable contact lens wearer (including ortho-k) within 6 months of the first visit • Have contraindications to contact lens wear • Have epilepsy or history of migraines exacerbated by flashing, strobe-like lights • Pregnancy (verbal self-report) or breastfeeding.
Outcome results
None listed