Evaluation of Stenfilcon A Versus Etafilcon A

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: Etafilcon A; Device: Stenfilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01809834

CV-12-57

Details and patient eligibility

About

Evaluation of two contact lenses

Full description

One week dispensing, investigator-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye simultaneously.

Enrollment: 46 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is at least 17 years of age and has full legal capacity to volunteer;
• Has read and signed an information consent letter;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses;
• Has astigmatism less than or equal to -1.00D;
• Is an adapted soft contact lens wearer;
• Demonstrates an acceptable fit with the study lenses;
• Has no active anterior segment disease or known ocular disease.

Exclusion criteria

• A person will be excluded from the study if he/she:
• 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, neovascularization, corneal scars or corneal opacities;
• Is aphakic;
• Has undergone corneal refractive surgery;
• Is participating in any other type of clinical or research study;
• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Etafilcon A

Active Comparator group

Description:

Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously

Treatment:

Device: Stenfilcon A

Stenfilcon A

Experimental group

Description:

Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously

Treatment:

Device: Etafilcon A