Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens

Study Overview
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Brief Summary
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The purpose of this study is to assess the clinical performance of an investigational contact lens over 30 days of daily wear.

Detailed Description
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Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 60 days (30 days for each product).

Official Title
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Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens

Conditions
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Myopia

Intervention / Treatment
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* Device: Lehfilcon A contact lenses
* Device: Comfilcon A contact lenses
* Device: CLEAR CARE


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Able to understand and sign an approved Informed Consent form; Willing and able to attend all scheduled study visits as required by the protocol; Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day; Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Current or prior Biofinity contact lens wearer in the past 3 months; Monovision contact lens wearer; Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LID018869, then Biofinity<br>Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection. | Device: Lehfilcon A contact lenses<br>* Investigational silicone hydrogel contact lenses<br>* Other names: LID018869;Device: Comfilcon A contact lenses<br>* Commercially available silicone hydrogel contact lenses<br>* Other names: Biofinity;Device: CLEAR CARE<br>* Hydrogen peroxide-based cleaning and disinfecting solution<br>|
| Other: Biofinity, then LID018869<br>Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection. | Device: Lehfilcon A contact lenses<br>* Investigational silicone hydrogel contact lenses<br>* Other names: LID018869;Device: Comfilcon A contact lenses<br>* Commercially available silicone hydrogel contact lenses<br>* Other names: Biofinity;Device: CLEAR CARE<br>* Hydrogen peroxide-based cleaning and disinfecting solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Distance Visual Acuity (logMAR) With Study Lenses | Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned. | Day 1, Day 30 after 6-8 hours of wear, each product | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lenses