Clinical Evaluation of Two Multifocal Contact Lenses

CooperVision

Status: Completed

Conditions: Presbyopia

Treatments: Device: Lens B; Device: Lens A

Study type: Interventional

Funder types: Industry

Identifiers

NCT05457608

EX-MKTG-136

Details and patient eligibility

About

The aim of this study is to evaluate the patient subjective experiences of the monthly multifocal lens when compared to the daily disposable multifocal lens after 15 minutes of daily wear.

Full description

This is a single-blind, interventional, prospective, direct refit, bilateral wear study.

Enrollment: 42 patients

Sex: All

Ages: 42+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Is at least 42 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.
• Habitually wears multifocal soft contact lenses, or sphere lenses for monovision, or sphere lenses for monovision, or sphere lenses for distance vision correction and use spectacles for near vision correction, for the past 3 months minimum.
• Has refractive astigmatism no higher than -0.75DC.
• Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D.
• 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 +4.00 to -6.00DS).

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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42 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