Assessing the Clinical Performance 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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-24

Study Completion Date

2023-02-21

Brief Summary

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The purpose of this clinical trial is to assess the clinical performance of LID223194 Multifocal (MF) contact lenses and commercially available Air Optix plus HydraGlyde (AOHG) MF contact lenses. Eligible subjects will wear each study lens type in a cross-over fashion as randomized for approximately 2 days.

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Detailed Description

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Subjects will be expected to attend 3 scheduled visits for an individual duration of participation of up to 10 days.

Conditions

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Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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LID223194 MF, then AOHG MF

Lehfilcon A multifocal contact lenses worn first, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product will be worn in both eyes for 2 days in a daily wear modality. CLEAR CARE will be used for daily cleaning and disinfection.

Group Type OTHER

Lehfilcon A multifocal contact lenses

Intervention Type DEVICE

Silicone hydrogel multifocal contact lenses

Lotrafilcon B multifocal contact lenses

Intervention Type DEVICE

Silicone hydrogel multifocal contact lenses

Hydrogen peroxide-based cleaning and disinfection system

Intervention Type DEVICE

Commercially available cleaning and disinfection system for silicone hydrogel contact lenses

AOHG MF, then LID223194 MF

Lotrafilcon B multifocal contact lenses worn first, followed by lehfilcon A multifocal contact lenses, as randomized. Each product will be worn in both eyes for 2 days in a daily wear modality. CLEAR CARE will be used for daily cleaning and disinfection.

Group Type OTHER

Lehfilcon A multifocal contact lenses

Intervention Type DEVICE

Silicone hydrogel multifocal contact lenses

Lotrafilcon B multifocal contact lenses

Intervention Type DEVICE

Silicone hydrogel multifocal contact lenses

Hydrogen peroxide-based cleaning and disinfection system

Intervention Type DEVICE

Commercially available cleaning and disinfection system for silicone hydrogel contact lenses

Interventions

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Lehfilcon A multifocal contact lenses

Silicone hydrogel multifocal contact lenses

Intervention Type DEVICE

Lotrafilcon B multifocal contact lenses

Silicone hydrogel multifocal contact lenses

Intervention Type DEVICE

Hydrogen peroxide-based cleaning and disinfection system

Commercially available cleaning and disinfection system for silicone hydrogel contact lenses

Intervention Type DEVICE

Other Intervention Names

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LID223194 MF contact lenses AOHG MF contact lenses CLEAR CARE

Eligibility Criteria

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Inclusion Criteria

* Able to understand and sign an consent form (ICF) that has been approved by an Institutional Review Board (IRB);
* Willing to stop wearing habitual contact lenses for the duration of study participation;
* Currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;

Exclusion Criteria

* Any eye infection, inflammation, or 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 plan to have refractive surgery during the study;
* Current or history of dry eye in either eye that would preclude contact lens wear, in the opinion of the investigator;
* Monovision contact lens wear;

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No