Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses

CooperVision

Status: Completed

Conditions: Myopia; Hyperopia

Treatments: Device: Lens B; Device: Lens A

Study type: Interventional

Funder types: Industry

Identifiers

NCT05656885

EX-MKTG-142

Details and patient eligibility

About

This was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study.

Full description

The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of two soft spherical contact lenses after 15 minutes of daily wear each.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Is at least 18 years of age and has full legal capacity to volunteer.
• Has read and signed an information consent letter.
• Self-reports having a full eye examination in the previous two years.
• Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Habitual soft contact lens wearers who currently wear sphere contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
• Has refractive astigmatism no higher than -0.75DC.
• Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +8.00 to -12.00DS)

Exclusion criteria

• Is participating in any concurrent clinical or research study.
• Has any known active ocular disease and/or infection that contraindicates contact lens wear.
• 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 contact lens wear or a study outcome variable.
• Has known sensitivity to the diagnostic sodium fluorescein used in the study.
• Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
• Has undergone refractive error surgery or intraocular surgery.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Lens A

Experimental group

Description:

All participants wore Lens A for 15 minutes (Period 1)

Treatment:

Device: Lens A

Lens B

Experimental group

Description:

All participants wore Lens B for 15 minutes (Period 2)

Treatment:

Device: Lens B