Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear

Launched by COOPERVISION, INC. · Sep 18, 2015

Keywords

ClinConnect Summary

Subjects will be randomized into the study contact lenses in a two to one (2:1) ratio of fanfilcon A lens (test) to enfilcon A lens (control). This should result in a study population of approximately 60 test subjects and 30 control subjects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Be at least 18 years of age as of the date of evaluation for the study.
• * Have:
• • Read the Informed Consent
• • Been given an explanation of the Informed Consent
• • Indicated understanding of the Informed Consent
• • Signed the Informed Consent document.
• • Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
• • Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses at least 5 days per week for at least 8 hours per day for at least one month prior to participation in the study.
• • Possess or obtain prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.
• • Be in good general health, based on his/her knowledge.
• • Require spectacle lens powers between -0.50 and -8.00 diopters sphere with no more than 1.50 diopter of refractive astigmatism and be willing to wear contact lenses in both eyes.
• • Have manifest refraction Snellen visual acuities (VA) equal to or better than20/25 in each eye.
• • To be eligible for lens dispensing, the subject must achieve 20/30 VA or better in each eye with the study lens and the investigator must judge the fit as acceptable or optimal.
• Exclusion Criteria:
• • Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes for the duration of the study. Note: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
• • Poor personal hygiene.
• • Any active participation in another clinical trial during this trial or within 30 days prior to this study.
• • To the best of the subject's knowledge, she is currently pregnant, is lactating or is planning a pregnancy within the next 3 months.
• • A member, relative or household member of the investigator or of the investigational office staff.
• • Has a known sensitivity to the ingredients used in the Multi-Purpose Disinfection Lens Care System (MPS) approved for use in the study and is unable or unwilling to use the alternate care system.
• • Previous refractive surgery; or current or previous orthokeratology treatment.
• • Is aphakic or pseudophakic.
• • Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, scleroderma, keratoconus or uncontrolled diabetes.
• • The need for topical ocular medications or any systemic medication which might interfere with contact lens wear or require the lenses to be removed during the day.
• • The presence of clinically significant (grade 2, 3 or 4) anterior segment abnormalities; or the presence of any inflammations such as iritis; or any infection of the eye, lids, or associated structures.
• • A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, iritis, bacterial or fungal infections.
• • A history of papillary conjunctivitis that has interfered with contact lens wear.
• * Slit lamp findings that would contraindicate contact lens wear, including but not limited to:
• • Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining \> Grade 2
• • Pterygium
• • Corneal scars within the visual axis
• • Neovascularization or ghost vessels \> 1.0 mm in from the limbus
• • Giant papillary conjunctivitis (GPC) of \> Grade 2
• • Anterior uveitis or iritis
• • Seborrheic eczema, seborrheic conjunctivitis or blepharitis