Performance of Wearers of Stenfilcon A Contact Lenses After A Refit With Test Lenses

CooperVision

Status

Completed

Conditions

Myopia

Treatments

Device: Test lens

Device: control lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT03496701

EX-MKTG-86

Details and patient eligibility

About

The aim of this study is to determine if habitual or adapted wearers of stenfilcon A control contact lenses can be refit into test lenses and be successful after one week of daily wear.

Full description

This study is a prospective, multi-center, open label, bilateral, daily wear, one week dispensing study comparing performance of wearers of stenfilcon A control contact lenses after refit with test contact lenses.

Enrollment

77 patients

Sex

All

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Is between 18 and 35 years of age (inclusive)
Has read and signed the informed consent letter
Is willing and anticipated to follow instructions and maintain the appointment schedule
Habitually wears soft spherical contact lenses with a power between -1.00D to -6.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day.
Habitually wears or is able to be adequately refit into MyDay Sphere lenses
Demonstrates an acceptable fit with the study lenses
Is correctable to a distance visual acuity of 0.20 logMAR (approximately 20/30) or better (in each eye) with the study contact lenses
Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week.
Manifest cylindrical spectacle refraction does not exceed -0.75DC in either eye
Has clear corneas and no active ocular disease
Has a contact lens refraction that fits within the available parameters of the study lenses.

Exclusion criteria

A person will be excluded from the study if he/she:

Is participating in any concurrent clinical research study
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
Has a systemic condition that, in the opinion of the investigator, may affect the study measures
Is using any systemic or topical medications that in the opinion of the investigator may affect the study measures.
Presents with slit lamp findings or clinically significant anterior segment abnormalities 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 a known sensitivity to the diagnostic pharmaceuticals to be used in the study
Has aphakia, keratoconus or a highly irregular cornea.
Has presbyopia or has dependence on spectacles for near work over the contact lenses.
Has undergone refractive surgery.
Is pregnant, lactating or planning a pregnancy (by verbal communication) at the time of enrollment
Has participated in any other type of eye related clinical or research study within the last 7 days
Is habitually using rewetting/ lubricating eye drops (more than once per day)