A Dispensing Clinical Trial of Test Contact Lens Against Marketed Contact Lens

CooperVision

Status

Completed

Conditions

Myopia

Treatments

Device: Control lens

Device: Test lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT03499067

CV-18-07

Details and patient eligibility

About

Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed lens (control), when worn on a daily basis for 1 month.

Full description

Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed silicone- hydrogel contact lens (control), when worn on a daily basis for 1 month.

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Has had a self-reported oculo-visual examination in the last two years.
Is at least 18 years of age and has full legal capacity to volunteer.
Has read and understood the information consent letter.
Is willing and able to follow instructions and maintain the appointment schedule.
Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
Currently wears soft contact lenses.
Requires spectacle lens powers between -0.75 to -6.50 diopters sphere (0.25D steps).
Has no more than 0.75 diopters of refractive astigmatism.
Has clear corneas and no active ocular disease.
Has not worn lenses for at least 12 hours before the examination.
Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit

Exclusion criteria

Has never worn contact lenses before.
Has any systemic disease affecting ocular health.
Is using any systemic or topical medications that will affect ocular health.
Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
Is aphakic.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.
Known allergy to a product used in this study (ex. Shellfish allergy)
Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).