Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-08

Study Completion Date

2023-03-30

Brief Summary

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The purpose of this clinical trial was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens.

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Detailed Description

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Subjects will be expected to attend 3 scheduled visits. Eligible subjects will wear each study lens type in a cross-over fashion for approximately 2 days.

Conditions

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Refractive Ametropia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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LID#224381, then AOHG MF

Lehfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection.

Group Type OTHER

Lehfilcon A multifocal contact lenses

Intervention Type DEVICE

Investigational silicone hydrogel multifocal contact lenses

Lotrafilcon B multifocal contact lenses

Intervention Type DEVICE

Commercially available 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 LID#224381

Lotrafilcon B multifocal contact lenses worn first, with lehfilcon A multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection.

Group Type OTHER

Lehfilcon A multifocal contact lenses

Intervention Type DEVICE

Investigational silicone hydrogel multifocal contact lenses

Lotrafilcon B multifocal contact lenses

Intervention Type DEVICE

Commercially available 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

Investigational silicone hydrogel multifocal contact lenses

Intervention Type DEVICE

Lotrafilcon B multifocal contact lenses

Commercially available 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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LID#224381 MF contact lenses AOHG MF contact lenses AIR OPTIX® plus HydraGlyde ® multifocal contact lenses (AOHG MF) 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