Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses

Launched by COOPERVISION, INC. · Sep 29, 2016

Keywords

ClinConnect Summary

The aim of this study is to determine if adapted contact lens wearers enfilcon A toric lenses can be confidently refit into fanfilcon A toric lenses and can be successful after one month of daily wear.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• A person is eligible for inclusion in the study if he/she:
• • Is between 18 and 40 years of age (inclusive)
• • Has had a self-reported eye exam in the last two years
• • Is a habitual soft toric lens wearer
• • Can be successfully fit with study lenses (≥ grade 2 fit acceptance)
• • Has a contact lens spherical prescription between -1.00 to -6.00D with a cylinder between -0.75 and -1.75D (Diopters) (inclusive)
• • Has a spectacle cylinder of at least 0.75D in each eye.
• • Can achieve best corrected spectacle refraction 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:
• • Has a history of not achieving comfortable CL (Contact Lens) wear (5 days per week; \> 8 hours/day)
• • Presents with clinically significant anterior segment abnormalities
• • Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear
• * 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
• • 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
• • Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
• • Has aphakia, keratoconus or a highly irregular cornea.
• • Has presbyopia or has dependence on spectacles for near work over the contact lenses.
• • Has undergone corneal refractive surgery.
• • Is participating in any other type of eye related clinical or research study.
• • Is frequently using rewetting/ lubricating eye drops (more than once per day)