Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear

Study Overview
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Brief Summary
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The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn continuously for up to 1 week.

Detailed Description
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Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Screening/Baseline/Dispense; Day 2 Follow-up within 4 hours of awakening (after the first night of sleeping); and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.

Official Title
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Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear

Conditions
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Refractive Errors, Myopia, Hyperopia

Intervention / Treatment
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* Device: Lehfilcon A contact lens
* Device: Comfilcon A contact lens


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Able to understand and sign an IRB/IEC approved Informed Consent form. Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days/week and in an extended wear modality at least 1 night/week. Best corrected visual acuity of 20/25 or better in each eye. Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator. Any habitual wear of Biofinity contact lenses. Pregnant or breast-feeding. 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: Parallel Assignment
Interventional Model Description: In this contralateral study, subjects will be randomized to wear the investigational lens in 1 eye and the control lens in the other eye.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LID018869 (OD) / Biofinity (OS)<br>Lehfilcon A contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear | Device: Lehfilcon A contact lens<br>* Investigational silicone hydrogel contact lens<br>* Other names: LID018869;Device: Comfilcon A contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: Biofinity;|
| Active Comparator: Biofinity (OD) / LID018869 (OS)<br>Comfilcon A contact lens worn in the right eye, with lehfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear | Device: Lehfilcon A contact lens<br>* Investigational silicone hydrogel contact lens<br>* Other names: LID018869;Device: Comfilcon A contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: Biofinity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Visual Acuity (VA) With Study Lenses | Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to 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 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/Exit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extended Wear, Contact Lens, Overnight Wear, Vision Correction, Contralateral Wear