Clinical Validation of the Apollo Daily Disposable Soft Contact Lenses

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: Control Lens; Device: Test Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT05035017

CV-20-63

Details and patient eligibility

About

The purpose of this study was to confirm the design specifications of a Test lens and validate its clinical performance.

Full description

This was a double-masked, randomized, bilateral two-day crossover, dispensing study design. Subjects were randomized to wear the Test lens or Control lens bilaterally in random order and on a daily wear, single-use basis for a period of 2 days each.

Enrollment: 35 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 an adapted soft contact lens wearer, having worn contact lenses for a minimum 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 20/20 in each eye.
• Wears CLs in both eyes (monovision 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 on at least two consecutive days for each study pair.

Exclusion criteria

• Has never worn contact lenses before.
• Has any systemic disease affecting ocular health.
• Is using any concomitant 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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35 participants in 2 patient groups

Test Lens, then Control Lens

Experimental group

Description:

Participants wore Test Lens for 2 days, and then Control Lens for 2 days

Treatment:

Device: Test Lens

Device: Control Lens

Control Lens, then Test Lens

Active Comparator group

Description:

Participants wore Control Lens for 2 days, and then Test Lens for 2 days

Treatment:

Device: Test Lens

Device: Control Lens