Assessment of Daily Disposable Silicone Hydrogel Lens Wear

Johnson & Johnson (J&J)

Status

Completed

Conditions

Myopia

Treatments

Device: Spectacles

Device: Narafilcon B Contact Lens

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01093625

CR-0916

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of an investigational silicone hydrogel soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle wearers.

Enrollment

157 patients

Sex

All

Ages

15 to 39 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Able to read, comprehend and sign an informed consent (or parental consent/subject assent, as appropriate).
Willing to comply with the study visit schedule.
Ages 15 to 39.
Has access to a cellular telephone with text messaging capabilities.
Has a current pair of spectacles.
'Neophyte' - In this work, 'neophyte' will be taken to mean any subject who has never been dispensed contact lenses. A subject who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses, will also be classified as a 'neophyte'.
Spherical contact lens (CL) prescription between -0.75D and -6.00D and spectacle cylinder equal to or less than 0.75 DC.
Monocular best-corrected distance visual acuity (VA) ≥ 20/30 Snellen in each eye.
Subject agrees to "intent" of wearing the CLs at minimum 6 hours/day for at least 4 days per week.
They agree not to participate in other clinical research during the duration of this study.

Exclusion criteria

Active ocular allergy, infection, injury, inflammation, or abnormality (e.g., keratoconus) that might interfere with soft contact lens wear.
Prior corneal refractive surgery or corneal irregularity (e.g., keratoconus).
Systemic disease, which might interfere with contact lens wear.
Medication usage that may be associated with eye dryness.
Use of any topical medication such as eye drops or ointment.
Pregnant or lactating (by self-report).
Aphakia.
Grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.
Have participated in any other clinical trial or research in the two weeks prior to starting this study.