None listed
Conditions
Brief summary
• The aim of this study is to evaluate the impact of contact lens disinfectants on ocular physiology, tear film characteristics, and symptomatology that might occur during contact lens wear. Participants will wear Comfilcon A contact lenses over a 6-week, changing their lenses every two weeks, a commonly recommended wear schedule and use new contact lens disinfectants (Cleadew MPS,Ophtecs Corp., Japan) • The primary endpoint is the changes in the ocular surface and tears of contact lens wearer over the first six weeks of lens wear using new lens care product. • The secondary endpoint is changes in factors that have been reported to be different between comfortable and uncomfortable contact lens wearers.
Interventions
The aim of this study is to evaluate the impact of contact lens disinfectants on ocular physiology, tear film characteristics, and symptomatology that might occur during contact lens wear.
We will ask participants to wear Comfilcon A contact lenses at least 5 days per week for at least 6 hours per day, wearing the same lenses for 2 weeks and then replaced with new lenses every 2 weeks, as a commonly recommended wear schedule.
Participants also will be asked to use new contact lens disinfectants
The aim of this study is to evaluate the impact of contact lens disinfectants on ocular physiology, tear film characteristics, and symptomatology that might occur during contact lens wear. We will ask participants to wear Comfilcon A contact lenses at least 5 days per week for at least 6 hours per day, wearing the same lenses for 2 weeks and then replaced with new lenses every 2 weeks, as a commonly recommended wear schedule. Participants also will be asked to use new contact lens disinfectants (Cleadew MPS,Ophtecs Corp., Japan) containing polyhexamethylene biguanide hydrochloride and Alexidine dihydrochloride as the main ingredients in the following manner: Every day after lens removal, gently rub and wash both sides of the lens with the disinfectant 20-30 times per side and soak the lens in the disinfectant for at least 4 hours or over nights. In addition, before wearing the lenses, participants will rinse them with the disinfectant for at least 5 seconds before starting to wear them. The eligible subjects will be provided with lenses and disinfectants and will be instructed cleaning/disinfection procedures at the first visit, and participants are then asked to have a clinical examination and sample collection for a total of one hour each time at the clinic three times: at the first visit, 3 weeks later (visit #2), and 6 weeks later (visit #3) with each visit lasting a total of approximately one hour. Clinical examinations include visual acuity test, slit-lamp biomicroscopy with corneal and conjunctival staining, phenol red thread test, contact lens dry eye questionnaire, tear volume, noninvasive tear fluid layer thickness, meibography, and noninvasive tear fluid layer thickness measurement. All the Interventions including examinations and instructions are performed by trained investigator, including optometrists and Japanese ophthalmologists.
Sponsors
University of New South Wales
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Aged 18 years or above • Willing to sign informed consent and comply with study schedule • Contact lens wearers who have worn lenses for at least 6 months, used contact lenses for 3 weeks before the evaluation visit and used these lenses at least four times a week. Contact lenses should have been worn on daily wear modality, where the lenses are worn for at least 6hours per day and remove the lenses before sleep. • Willing to wear their lenses a minimum of 6 hours per day at least 5 days per week for the duration of the study (6 weeks), and to cooperate with the required procedures of diagnostic agent installation, eyelid eversion, and examination. • Willing to not use any rewetting eye drops for the duration of the study and to refrain from swimming, showering and/or sleeping while wearing the contact lenses for the duration of the study • No noticeable scarring of the ocular surface that should avoid CL wear (no grade 2 or higher staining as a result of a single drop of nonconservative fluorescein solution and examination 1 minute after the drop).
Exclusion criteria
• Any ocular or systemic disease that might influence the tear film or ability to safely wear contact lenses. • Any history of previous ocular surgery or trauma, including chalazion exclusion, oculoplastic surgery. • Be pregnant, planning to become pregnant during the 6 weeks of the study or be lactating (any participant that does become pregnant during the study should inform the study personnel immediately so that they can be withdrawn from the study since the increased level of hormones can impact ocular comfort during lens wear). • Current use of any prescription on non-prescription ocular or systemic medications, including antihistamines. • Would be likely to use artificial tear preparations during the period 4 hours before all visits. Use of any ocular ointment during the 3 days before all visits.
Outcome results
None listed