Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-18

Study Completion Date

2024-10-08

Brief Summary

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The purpose of this study is to evaluate the on-eye multifocal clinical performance of investigational LID233309 contact lenses and Oasys multifocal (MF) contact lenses in a daily wear dispensing trial.

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Detailed Description

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Subjects will wear two different contact lens study products in a cross-over fashion. Each study product type will be worn for approximately 14 days. A washout period of 2-4 days will occur prior to the first wear period and between the two wear periods. Subjects will be expected to attend 7 office visits. The total duration of study participation is approximately 40 days with approximately 28 days of lens wear.

Conditions

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Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LID233309, then Oasys MF

Serafilcon A multifocal contact lenses worn in Period 1, followed by senofilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection.

Group Type OTHER

Serafilcon A multifocal contact lenses

Intervention Type DEVICE

Investigational multifocal soft contact lenses

Senofilcon A multifocal contact lenses

Intervention Type DEVICE

Commercially available multifocal soft contact lenses

CLEAR CARE® Cleaning & Disinfecting Solution

Intervention Type DEVICE

Hydrogen peroxide-based contact lens cleaning and disinfection system

Oasys MF, then LID233309

Senofilcon A multifocal contact lenses worn in Period 1, followed by serafilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection.

Group Type OTHER

Serafilcon A multifocal contact lenses

Intervention Type DEVICE

Investigational multifocal soft contact lenses

Senofilcon A multifocal contact lenses

Intervention Type DEVICE

Commercially available multifocal soft contact lenses

CLEAR CARE® Cleaning & Disinfecting Solution

Intervention Type DEVICE

Hydrogen peroxide-based contact lens cleaning and disinfection system

Interventions

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Serafilcon A multifocal contact lenses

Investigational multifocal soft contact lenses

Intervention Type DEVICE

Senofilcon A multifocal contact lenses

Commercially available multifocal soft contact lenses

Intervention Type DEVICE

CLEAR CARE® Cleaning & Disinfecting Solution

Hydrogen peroxide-based contact lens cleaning and disinfection system

Intervention Type DEVICE

Other Intervention Names

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LID233309 ACUVUE® OASYS MULTIFOCAL with PUPIL OPTIMIZED DESIGN Oasys MF CLEAR CARE

Eligibility Criteria

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Inclusion Criteria

* Current wearer of biweekly/monthly replacement multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 6 months.
* Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
* Able to wear contact lenses within the available power range with a near ADD of +0.75 D to +2.50 D in each eye.

Exclusion Criteria

* Currently pregnant or lactating.
* History of amblyopia, strabismus, or binocular vision abnormalities.
* Habitual Oasys MF contact lens wearers or daily disposable contact lens wearers.
* Monovision contact lens wearers and wearers of contact lens in one eye only.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No