Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks

CooperVision

Status

Completed

Conditions

Myopia

Treatments

Device: fanfilcon A (test)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02670473

EX-MKTG-55 (CV-15-09)

Details and patient eligibility

About

The aim of this dispensing study is to evaluate the clinical performance of habitual wearers of enfilcon A lenses following a refit with fanfilcon A lenses over 4 weeks of daily wear.

Full description

This is a 30 subject, prospective, dispensing, bilateral wear, subject-masked study, reviewing the refit characteristics in a group of enfilcon A wearers switched to the fanfilcon A lens. Subject's habitual enfilcon A lenses will be evaluated at the first vist and then re-fitted with a pair of fanfilcon A lenses for 4 weeks of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks, and 4 weeks.

Enrollment

35 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

A person is eligible for inclusion in the study if he/she:

Is between 18 and 40 years of age
Has had a self-reported visual exam in the last two years
Is an adapted enfilcon A contact lens wearer (at least 2 weeks in enfilcon A lens)
Has a contact lens spherical prescription between -1.00 to - 6.00
Has a spectacle cylinder up to 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
Has read, understood, and signed the information consent letter.
Patient contact lens refraction should fit 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:

Is not a habitual wearer of enfilcon A lenses
Has a CL (Contact Lens) prescription outside the range of the available parameters of the study lenses.
Has a spectacle cylinder ≥1.00D of cylinder in either eye.
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
Presence of clinically significant (grade 3-4) anterior segment abnormalities
Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
Slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- 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 (past or present)
- Seborrheic eczema, 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.