A One-Week Crossover Dispensing Evaluation of New Daily Wear Soft Contact Lenses

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: Nelfilcon A; Device: Test Contact Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT03306641

CV-17-29

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 1 week 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 1 week compared to nelfilcon A (control). The primary outcomes of interest is lens fit acceptance.

Enrollment: 45 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is at least 18 years of age and has full legal capacity to volunteer.
• Is no greater than 55 years of age.
• Has read and understood the information consent letter.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.
• 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.
• Wears CLs in both eyes (monvision acceptable, but not monofit)
• Has clear corneas and no active ocular disease.
• Has not worn lenses for at least 12 hours before the examination.
• Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week

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 strabismus/amblyopia.
• Has undergone corneal refractive surgery.
• Is pregnant, lactating or planning a pregnancy.
• Is participating in any concurrent clinical or research study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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45 participants in 2 patient groups

Test Contact Lens

Active Comparator group

Description:

Per randomized schedule, subject will wear a pair of the test lens or control lens for one week and then cross-over with the control pair for 1 week.

Treatment:

Device: Test Contact Lens

Device: Nelfilcon A

nelfilcon A lens (control)

Active Comparator group

Description:

Per randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week.

Treatment:

Device: Test Contact Lens

Device: Nelfilcon A