Clinical Evaluation of Stenfilcon A Contact Lenses
Status
Completed
Conditions
Myopia
Treatments
Device: narafilcon A lens
Device: stenfilcon A lens
Details and patient eligibility
About
This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control).
Full description
This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control) over 3 hour of wear time in a Japanese population.
Enrollment
40 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
A person is eligible for inclusion in the study if he/she:
- Is Japanese
- Has had a self-reported oculo-visual examination in the last two years.
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and understood the informed consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- Currently wears soft contact lenses.
- Has clear corneas and no active ocular disease.
Exclusion criteria
A person will be excluded from the study if he/she:
- Has never worn contact lenses before.
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- Is aphakic.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Single Blind
40 participants in 2 patient groups
stenfilcon A lens
Experimental group
Description:
MyDay contact lens
Treatment:
Device: stenfilcon A lens
narafilcon A lens
Active Comparator group
Description:
1-Day Acuvue TruEye
Treatment:
Device: narafilcon A lens
Trial contacts and locations
4
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Data sourced from clinicaltrials.gov
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