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

Study Overview
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Brief Summary
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The purpose of this clinical trial is to assess the clinical performance of LID#224381 Multifocal (MF) contact lens and Air Optix plus HydraGlyde (AOHG), a commercially available MF contact lens. Eligible subjects will wear each study lens type in a cross-over fashion for approximately 2 days.

Detailed Description
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Subjects will be expected to attend 3 scheduled visits.

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

Conditions
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Presbyopia

Intervention / Treatment
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* Device: Lehfilcon A multlifocal contact lenses
* Device: Lotrafilcon B multifocal contact lenses
* Device: Hydrogen peroxide-based cleaning and disinfection system


Participation Criteria
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Eligibility Criteria
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Key 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; Other protocol-defined inclusion criteria may apply. Key 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; Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LID#224381, then AOHG MF<br>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. | Device: Lehfilcon A multlifocal contact lenses<br>* Investigational silicone hydrogel multifocal contact lenses<br>* Other names: LID#224381 MF contact lenses;Device: Lotrafilcon B multifocal contact lenses<br>* Commercially available silicone hydrogel multifocal contact lenses<br>* Other names: AIR OPTIX® plus HydraGlyde ® multifocal contact lenses;Device: Hydrogen peroxide-based cleaning and disinfection system<br>* Commercially available cleaning and disinfection system for silicone hydrogel contact lenses<br>* Other names: CLEAR CARE®;|
| Other: AOHG MF, then LID#224381<br>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. | Device: Lehfilcon A multlifocal contact lenses<br>* Investigational silicone hydrogel multifocal contact lenses<br>* Other names: LID#224381 MF contact lenses;Device: Lotrafilcon B multifocal contact lenses<br>* Commercially available silicone hydrogel multifocal contact lenses<br>* Other names: AIR OPTIX® plus HydraGlyde ® multifocal contact lenses;Device: Hydrogen peroxide-based cleaning and disinfection system<br>* Commercially available cleaning and disinfection system for silicone hydrogel contact lenses<br>* Other names: CLEAR CARE®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular Visual Acuity (VA) with Study Lenses at 4 meters (logMAR) | VA will be assessed binocularly (both eyes together) using a letter chart and measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. | Day 2, each study lens type |