Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses

Completed · Not applicable

Conditions studied: Myopia

In brief

Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1 month dispensing study (2 weeks each lens pair)

Key facts

Study ID

NCT02956460

Run by

CooperVision, Inc.

People needed

64

Starts

2016-10-27

Expected to finish

2016-12-14

Last updated by the study team

2018-04-02

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A person is eligible for inclusion in the study if he/she:
• Is between 18 and 40 years of age (inclusive)
• Has read, understood and signed the information consent letter
• Has had a self-reported eye exam in the last two years
• Is a spherical soft contact lens wearer
• Has a contact lens prescription that fits within the available parameters of the study lenses
• 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
• Is willing and anticipated to be able to comply with the wear schedule (8 hours per day; 5 days a week of lens wear)
• Is willing and able to follow instructions and maintain the appointment schedule

You may not qualify if…

• A person will be excluded from the study if he/she:
• Has a history of not achieving comfortable CL (Contact Lens) wear (defined as 5 days per week; >8 hours/day)
• Is currently wearing senofilcon C (2 weeks lens), senofilcon A 1-Day, senofilcon C (monthly lens) or enfilcon A contact lenses
• Is habitually using rewetting/ lubricating eye drops more than once per 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
• 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
• 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

Where it is running

• Eric M. White O. D., Inc — San Diego, California, United States
• Golden Vision — Sarasota, Florida, United States
• Kannarr Eye Care — Pittsburg, Kansas, United States
• Nittany Eye Associates — State College, Pennsylvania, United States

Full record on ClinicalTrials.gov

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