Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens

Study Overview
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Brief Summary
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The purpose of this clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.

Detailed Description
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Subjects are expected to attend 6 study visits. The expected duration of study lens exposure is approximately 3 months.

Official Title
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Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel 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: CLEAR CARE


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day. Manifest cylinder equal to or less than 0.75 diopter (D) in each eye. Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment. Habitually wearing Biofinity contact lenses. Monovision contact lens wearers. 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LID018869<br>Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period. | Device: Lehfilcon A contact lenses<br>* Investigational silicone hydrogel contact lenses<br>* Other names: LID018869;Device: CLEAR CARE<br>* Hydrogen peroxide-based system for cleaning and disinfecting silicone hydrogel contact lenses<br>* Other names: CLEAR CARE® Cleaning & Disinfecting Solution;|
| Active Comparator: Biofinity<br>Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period. | Device: Comfilcon A contact lenses<br>* Commercially available silicone hydrogel contact lenses<br>* Other names: Biofinity;Device: CLEAR CARE<br>* Hydrogen peroxide-based system for cleaning and disinfecting silicone hydrogel contact lenses<br>* Other names: CLEAR CARE® Cleaning & Disinfecting Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance VA (logMAR) With Study Lenses - Completed Eyes | 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. | Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit) | 
| Distance VA (logMAR) With Study Lenses - Discontinued Eyes | 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. | Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up | 

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