Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-27

Study Completion Date

2022-09-01

Brief Summary

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The primary objective of this study is to demonstrate noninferiority in visual acuity at distance when wearing the test contact lenses (LID210464) compared to the control contact lenses (AOHG MF) after 30 days of wear.

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Detailed Description

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Subjects will be expected to attend 4 office visits and will be dispensed study contact lenses (test lenses and control lenses) for a 30-day duration of bilateral wear for each study lens type (total of approximately 60 days of contact 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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LID210464, then AOHG MF

Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.

Group Type OTHER

Lehfilcon A multifocal contact lenses

Intervention Type DEVICE

Investigational frequent replacement soft contact lens indicated for the optical correction of presbyopia

Lotrafilcon B multifocal contact lenses

Intervention Type DEVICE

Commercially available frequent replacement soft contact lens indicated for the optical correction of presbyopia

CLEAR CARE®

Intervention Type DEVICE

Hydrogen peroxide-based contact lens cleaning and disinfecting solution

AOHG MF, then LID210464

Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.

Group Type OTHER

Lehfilcon A multifocal contact lenses

Intervention Type DEVICE

Investigational frequent replacement soft contact lens indicated for the optical correction of presbyopia

Lotrafilcon B multifocal contact lenses

Intervention Type DEVICE

Commercially available frequent replacement soft contact lens indicated for the optical correction of presbyopia

CLEAR CARE®

Intervention Type DEVICE

Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Interventions

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Lehfilcon A multifocal contact lenses

Investigational frequent replacement soft contact lens indicated for the optical correction of presbyopia

Intervention Type DEVICE

Lotrafilcon B multifocal contact lenses

Commercially available frequent replacement soft contact lens indicated for the optical correction of presbyopia

Intervention Type DEVICE

CLEAR CARE®

Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Intervention Type DEVICE

Other Intervention Names

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LID210464 AOHG MF AIR OPTIX® plus HydraGlyde® Multifocal (AOHG MF) contact lenses

Eligibility Criteria

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Inclusion Criteria

* Able to understand and sign an informed consent form that has been approved by an Institutional Review Board.
* Willing and able to attend all study visits as required by the protocol.
* Willing to stop wearing habitual contact lenses for the duration of the study.
* Currently wearing daily disposable and biweekly/monthly replacement multifocal soft contact lenses in both eyes at least 5 days per week and at least 8 hours per day for at least 3 months. AOHG MF wearers may be included.

Exclusion Criteria

* Any eye infection, inflammation, abnormality, or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
* History of refractive surgery or planning to have refractive surgery during the study.
* Current or history of pathologically dry eye.
* Currently pregnant or lactating.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No