Clinical Performance 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 obtain on-eye performance data to inform contact lens product development.

Detailed Description
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Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.

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

Conditions
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Refractive Errors

Intervention / Treatment
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* Device: Lehfilcon A contact lenses
* Device: Comfilcon A contact lenses
* Device: Multi-purpose disinfection solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign Informed Consent document. Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months. Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes. Other protocol-specified inclusion criteria may apply. Exclusion Criteria Any eye condition or disease or use of medication that contraindicates contact lens wear. Eye surgery, irregular cornea, eye injury as specified in the protocol. Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment. Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear. Habitually wears Biofinity 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LID017569, 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 on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection. | Device: Lehfilcon A contact lenses<br>* Investigational silicone hydrogel contact lenses<br>* Other names: LID017569;Device: Comfilcon A contact lenses<br>* Commercially available silicone hydrogel contact lenses<br>* Other names: Biofinity®;Device: Multi-purpose disinfection solution<br>* Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses<br>* Other names: OPTI-FREE® RepleniSH®;|
| Other: Biofinity, then LID017569<br>Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection. | Device: Lehfilcon A contact lenses<br>* Investigational silicone hydrogel contact lenses<br>* Other names: LID017569;Device: Comfilcon A contact lenses<br>* Commercially available silicone hydrogel contact lenses<br>* Other names: Biofinity®;Device: Multi-purpose disinfection solution<br>* Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses<br>* Other names: OPTI-FREE® RepleniSH®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance VA (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). 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 30 after a minimum of 6 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