One Month Dispensing Study Comparing the Clinical Performance of the Comfilcon A Sphere Lenses Compared to Comfilcon A Asphere Lenses.
Status
Conditions
Treatments
Details and patient eligibility
About
This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit, subjects will return for follow-up evaluations after 2 weeks, and 1 month.
Full description
This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit, subjects will return for follow-up evaluations after 2 weeks, and 1 month.
Both comfilcon A sphere lens (control) and comfilcon A asphere lens (test) are Coopervison lenses.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion criteria
A person is eligible for inclusion in the study if he/she:
- Is between 18 and 34 years of age (inclusive)
- Has had a self-reported eye exam in the last two years
- Is an adapted comfilcon A sphere contact lens wearer
- Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week.
- Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)
- Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye.
- Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
- Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
- Has clear corneas and no active ocular disease
- Has read, understood and signed the information consent letter.
- Has a contact lens refraction that fits within the available parameters of the study lenses.
- Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
- Is willing to comply with the visit schedule
Exclusion Criteria
A person will be excluded from the study if he/she:
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Has a history of not achieving comfortable CL (Contact Lens) wear (5 days per week; > 8 hours/day)
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Presents with clinically significant anterior segment abnormalities
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Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear.
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Presents with slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Significant pterygium, pinguecula, or corneal scars within the visual axis
- Neovascularization > 0.75 mm in from of the limbus
- Giant papillary conjunctivitis (GCP) worse than grade 1
- Anterior uveitis or iritis (or history in past year)
- Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
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Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
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Has aphakia, keratoconus or a highly irregular cornea.
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Has presbyopia or has dependence on spectacles for near work over the contact lenses.
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Has undergone corneal refractive surgery.
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Is participating in any other type of eye related clinical or research study.
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Is habitually using rewetting/ lubricating eye drops (more than once per day)
Trial design
Primary purpose
Allocation
Interventional model
Masking
54 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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