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

CooperVision

Status: Completed

Conditions: Astigmatism

Treatments: Device: fanfilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02921412

EX-MKTG-67

Details and patient eligibility

About

This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month dispensing study

Full description

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.

Enrollment: 37 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 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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37 participants in 2 patient groups

enfilcon A (habitual)

No Intervention group

Description:

All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.

fanfilcon A

Active Comparator group

Description:

All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.

Treatment:

Device: fanfilcon A