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

Completed · Not applicable

Conditions studied: Myopia

In brief

This study is a masked, multi-center, daily wear, monthly replacement, bilateral, randomized, lens blocked (subjects remain in the same lens brand throughout the study) concurrent control study enrolling up to 90 subjects with a study duration of approximately three months. 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).

Key facts

Study ID

NCT02555722

Run by

CooperVision, Inc.

People needed

92

Starts

2015-09-21

Expected to finish

2016-05-01

Last updated by the study team

2019-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Eric White, O.D., Inc. — San Diego, California, United States
• Mark Nakano, O.D. — Torrance, California, United States
• Advanced Family Eye Care — Denver, North Carolina, United States
• Quinn, Foster & Associates — Athens, Ohio, United States
• Western Reserve Vision Care, Inc. — Beachwood, Ohio, United States
• Primary Eyecare Group, P.C. — Brentwood, Tennessee, United States

Full record on ClinicalTrials.gov

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