Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses

Study Overview
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Brief Summary
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The purpose of this study is to compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear.

Detailed Description
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Subjects will be expected to attend 6 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over a 30-day period for each study lens type. The total duration of a subject's participation in the study will be approximately 65 days.

Official Title
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Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses

Conditions
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Refractive Errors

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


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Current wearer of a commercial spherical weekly/monthly soft contact lenses with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day. Manifest cylinder less than or equal to 0.75 diopter in each eye. Best corrected distance visual acuity better than or equal to 20/25 Snellen in each eye. Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Monovision or multifocal lens wearer. Habitual senofilcon contact lens wearer (for example, Acuvue Oasys, Acuvue Vita) or commercially available lehfilcon A contact lens wearer (TOTAL30). Routinely sleeps in habitual contact lenses. 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 AOHP<br>Lehfilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection. | Device: Lehfilcon A contact lenses<br>* Commercially available, silicone hydrogel, spherical contact lenses used as indicated<br>* Other names: LID018869;Device: Senofilcon A contact lenses<br>* Commercially available, silicone hydrogel, spherical contact lenses used as indicated<br>* Other names: AOHP;Device: CLEAR CARE<br>* Hydrogen peroxide-based contact lens cleaning and disinfecting solution<br>|
| Other: AOHP, then LID018869<br>Senofilcon A contact lenses worn in Period 1, followed by lehfilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection. | Device: Lehfilcon A contact lenses<br>* Commercially available, silicone hydrogel, spherical contact lenses used as indicated<br>* Other names: LID018869;Device: Senofilcon A contact lenses<br>* Commercially available, silicone hydrogel, spherical contact lenses used as indicated<br>* Other names: AOHP;Device: CLEAR CARE<br>* Hydrogen peroxide-based contact lens cleaning and disinfecting solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30 | 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). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. | Day 30, each study lens type | 

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