Comparison of New Contact Lens With Current Marketed Lens

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: Phoebe test lens; Device: stenfilcon A lens (control)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03360110

CV-17-60

Details and patient eligibility

About

The purpose of this study is to validate the clinical performance of a new contact lens design.

Full description

Evaluate the clinical performance of its Phoebe contact lenses (Test) compared to the commercially available MyDay contact lenses (Control).

Enrollment: 53 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

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

• Between and 18 and 35 years of age and has full legal capacity to volunteer
• Has had a self-reported oculo-visual examination in the last two years
• 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 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
• Has a Contact Lens Refraction between -1.00D and -6.00D
• Cylinder power ≤ -0.75DC in Spherical Cylindrical Refraction
• Currently wears soft contact lenses
• Is willing to wear lenses for a minimal of 8 hours a day and everyday during the course of the study
• Has clear corneas and no active ocular disease
• Has not worn lenses for at least 12 hours before the first visit

Exclusion Criteria

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

• Has never worn contact lenses before
• Is wearing Monovision modality
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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53 participants in 2 patient groups

Test lens

Active Comparator group

Description:

Subjects randomized to wear pair of test lens either first or second

Treatment:

Device: stenfilcon A lens (control)

Device: Phoebe test lens

stenfilcon A lens (control)

Active Comparator group

Description:

Subjects randomized to wear pair of control lens either first or second

Treatment:

Device: stenfilcon A lens (control)

Device: Phoebe test lens