Clinical Performance 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 assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.

Detailed Description
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In this crossover study, subjects will wear each study lens type for approximately 14 days and attend 7 scheduled visits. The expected duration of subject participation in the study is approximately 28 days (approximately 14 days per each study lens type).

Official Title
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Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

Conditions
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Refractive Errors

Intervention / Treatment
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* Device: Serafilcon 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: Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months. Best Corrected Visual Acuity of 20/25 Snellen (0.10 logMAR) or better in each eye. Willing to stop wearing habitual contact lenses for the duration of study participation. Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: Any eye infection, inflammation, 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. Habitual wear of AOHP contact lenses. Habitual wear of any daily disposable contact lenses. Other protocol-specified 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: LID022821, then AOHP<br>Serafilcon A contact lenses worn during Period 1, with senofilcon A contact lenses worn during Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. The serafilcon A contact lenses will be replaced with a fresh pair at the Week 1 follow-up visit. | Device: Serafilcon A contact lenses<br>* Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection<br>* Other names: LID022821;Device: Senofilcon A contact lenses<br>* Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection<br>* Other names: AOHP;Device: CLEAR CARE<br>* Hydrogen peroxide based contact lens cleaning and disinfecting solution<br>* Other names: CLEAR CARE® Cleaning and Disinfecting Solution;|
| Other: AOHP, then LID022821<br>Senofilcon A contact lenses worn during Period 1, with serafilcon A contact lenses worn during Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. The serafilcon A contact lenses will be replaced with a fresh pair at the Week 1 follow-up visit. | Device: Serafilcon A contact lenses<br>* Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection<br>* Other names: LID022821;Device: Senofilcon A contact lenses<br>* Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection<br>* Other names: AOHP;Device: CLEAR CARE<br>* Hydrogen peroxide based contact lens cleaning and disinfecting solution<br>* Other names: CLEAR CARE® Cleaning and Disinfecting Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity With Study Lenses at Week 1 Follow-Up | Visual acuity (VA) was assessed with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. Each eye was assessed individually. No hypothesis testing was pre-specified for this endpoint. | Week 1, each wear period. A wear period was approximately 14 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia