A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: Test Lens; Device: Control Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT03235089

CV-17-46

Details and patient eligibility

About

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control).

Full description

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control). The primary outcomes of interest are lens fit and lens fit preference.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is at least 18 years of age and has full legal capacity to volunteer
• Has read, fully understood and signed the information consent letter
• Currently wears or has previously worn soft contact lenses
• Has spectacle cylinder ≤1.00D in both eyes.
• Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
• Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.
• Has clear corneas and no active ocular disease
• Is willing and able to follow product usage instructions and maintain the visit schedule.

Exclusion criteria

• Has never worn contact lenses before
• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable
• Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
• Has any known active ocular disease and/or infection
• Has a monovision correction
• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses
• Is aphakic
• Has undergone corneal refractive surgery
• Is pregnant or lactating, determined by self-report

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 2 patient groups

Test lens

Active Comparator group

Description:

Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).

Treatment:

Device: Test Lens

Device: Control Lens

nelfilcon A lens (control)

Active Comparator group

Description:

Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).

Treatment:

Device: Test Lens

Device: Control Lens