None listed
Conditions
Brief summary
The aim of this study is to evaluate the impact of contact lens disinfectant on ocular physiology, tear film characteristics, and symptomatology that might occur during contact lens wear. Participants will wear Comfilcon A contact lenses over a 12-week, changing their lenses every four weeks, a commonly recommended wear schedule and use a new contact lens disinfectant made by Ophtecs Corp (Japan). • The primary endpoint is the changes in the ocular surface and tears of contact lens wearer over the first four weeks of lens wear using a 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 effect of contact lens disinfectant 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 over a 12 weeks (at least 6-8 hours, 5 days a week), changing their lenses every four weeks, a commonly recommended wear schedule.
Participants also will be asked to use a new contact lens disinfectant made by Ophtecs corp (Japan) containing polyhexame
The aim of this study is to evaluate the effect of contact lens disinfectant 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 over a 12 weeks (at least 6-8 hours, 5 days a week), changing their lenses every four weeks, a commonly recommended wear schedule. Participants also will be asked to use a new contact lens disinfectant made by 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 contact lens disinfectants at the first visit, and participants are then asked to have a clinical examination and sample collection at the clinic four times: at the first visit, 4 weeks later (visit #2), 8 weeks later (visit #3) and 12 weeks later (visit #4).The first visit will take about 90 minutes and the second and subsequent visits take about 60 minutes. All the Interventions including examinations and instructions are performed by trained investigator, including optometrists and Japanese ophthalmologists.In addition, there are no plans to monitor adherence to the intervention.
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
• Be at least 18 years of age, • Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. • 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 (12 weeks), • 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. • Willing to undergo the tests outlined in the section 3 of this form. • Experience symptoms of contact lens discomfort (CLD), defined as CLDEQ-8 Questionnaire score more than 13. • Have health and ocular health, defined as no fluorescein after a single instillation of non-preserved fluorescein solution followed by examination 1 minute after instillation, considering minimal staining of grade 1 as normal in contact lens wearers. • Normal corrected vision, defined as a minimum of 20/40 best corrected visual acuity in each eye.
Exclusion criteria
• Any active corneal infection, allergies, and Acute or sub-acute inflammation of the anterior chamber. • Severe insufficiency of lacrimal secretion (dry eye, less than or equal to 10mm for Phenol red thread test at Baseline). • Any systemic disease or medication use that may affect the eye such as diabetes and use of antihistamines, • People who have undergone corneal refractive surgery and neurological disorder such as epilepsy. • 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).
Outcome results
None listed