None listed
Conditions
Brief summary
Contact lens wear affects mucin expression on the ocular surface and in the tear fluid. The mucin change correlates with clinical variables and lens performance.
Interventions
A prospective, randomised, contralateral lens wear, open label, single group design clinical trial. with participants wearing comercially available lenses (AIR OPTIX AQUA and PUREVISION) and lens care solution (AOSEPT PLUS). Lenses will be worn for one month and a minimum of 6 hours per day, 5 days per week, on a daily wear basis (i.e. removed prior to sleep). Lenses will be disinfected overnight (minimum of 6 hours) in the lens care solution.
Sponsors
Institute for Eye Research
Study design
Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent; Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator; Have ocular health findings considered to be “normal” and which would not prevent the participant from safely wearing contact lenses; Has vision correctable to at least 6/12 (20/40) or better in each eye with contact lenses.
Exclusion criteria
Regular contact lens wearers; Pre-existing ocular irritation that would preclude contact lens fitting; Any ocular condition that may preclude safe wearing of contact lenses e.g. active corneal infection, severe dry eye, reduced corneal sensitivity, exophthalmos/lagophthalmos, facial nerve palsy; Active corneal infection (bacterial, viral, fungal or protozoan) or any active ocular disease such as iritis, corneal edema or corneal dystrophies, including anterior membrane dystrophy that would affect wearing of contact lenses; Use of any of the following medications (including steroids) up to 12 weeks prior to start of the clinical trial, or during the course of the trial: Ocular medication, category S3 and above; Any systemic or topical medications that will affect ocular physiology or the performance of the lenses e.g. anti-acne medications such as Roaccutane and corticosteroid or immunosuppressant medications such as Hydrocortisone, Prednisolone; Any systemic disease that may affect ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankolysing spondylitis, multiple sclerosis, Sjogrens syndrome and systemic lupus erythematosis; Conditions such as systemic hypertension do not automatically exclude prospective participants; Eye surgery within 12 weeks immediately prior to enrolment for this trial; Previous corneal refractive surgery; Any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would affect the wearing of contact lenses; Contraindications to hydrogel contact lens wear; Currently enrolled in another clinical trial;. Be pregnant or breast feeding;*. Allergy or intolerance to topical anaesthetics. *verbal report of pregnancy by the participant is sufficient, formal testing not required
Outcome results
None listed