Clinical Assessment of Two Daily Wear Monthly Replacement Soft 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 TOTAL30 contact lenses with Biofinity contact lenses 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 65 days, which includes approximately 30 days of exposure to the test product and approximately 30 days of exposure to the comparator product.

Official Title
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Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses

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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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; Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day; Manifest cylinder less than or equal to 0.75 diopter (D) in each eye; Willing to stop wearing habitual contact lenses for the duration of study participation. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any eye condition that contraindicates contact lens wear, as determined by the Investigator; Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator; Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study; Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear; Current or prior Biofinity contact lens wear in the past 3 months prior to consent. 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: TOTAL30, then Biofinity<br>Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses as randomized. Each study product will be worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection. | Device: Lehfilcon A contact lenses<br>* Investigational silicone hydrogel contact lenses<br>* Other names: TOTAL30;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 TOTAL30<br>Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product will be worn bilaterally (in both eyes) for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection. | Device: Lehfilcon A contact lenses<br>* Investigational silicone hydrogel contact lenses<br>* Other names: TOTAL30;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 |
| --- | --- | --- |
| Least Squares Mean Distance VA (logMAR) With Study Lenses | Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately 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. | Day 30, each study product | 

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