Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: fanfilcon A; Device: senofilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02956460

EX-MKTG-73

Details and patient eligibility

About

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

Full description

The aim of this study is to determine the clinical performance of fanfilcon A in comparison to senofilcon A sphere contact lenses.

Enrollment: 64 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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64 participants in 2 patient groups

fanfilcon A

Active Comparator group

Description:

Participants are randomized to wear fanfilcon A for two weeks during the cross over study.

Treatment:

Device: fanfilcon A

senofilcon A

Active Comparator group

Description:

Participants are randomized to wear senofilcon A for two weeks during the cross over study.

Treatment:

Device: senofilcon A