Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).

Detailed Description
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Part A of this study is a randomized, double masked, crossover study comparing 2 contact lens products. The expected duration of subject participation in Part A is approximately 8 weeks with 5 scheduled visits. Part B of this study is a non-randomized, single masked, single group study with 1 contact lens product. The expected duration of subject participation in Part B is approximately 4 weeks with 3 scheduled visits.

Official Title
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Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses

Conditions
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Refractive Errors, Ametropia

Intervention / Treatment
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* Device: Lehfilcon A contact lenses
* Device: Senofilcon A contact lenses
* Device: Comfilcon A contact lenses
* Device: Hydrogen peroxide-based cleaning and disinfecting solution


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Sign an approved Informed Consent Form. Wear spherical contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months. Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed. Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Any eye condition or use of medication that contraindicates contact lens wear, as determined by the Investigator. History of refractive surgery or plan to have refractive surgery during the study. Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear. Routinely sleeps in contact lenses at least 1 night per week. Part A: Current wearer of ACUVUE OASYS® with HYDRACLEAR® PLUS. Part B: Current wearer of Biofinity family of contact lenses (comfilcon A). 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
Interventional Model Description: Part A is a crossover study. Part B is a single group study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LID018869, then AOHP (Part A)<br>Lehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. | Device: Lehfilcon A contact lenses<br>* Investigational soft contact lenses for daily wear worn in Part A of the study<br>* Other names: LID018869;Device: Senofilcon A contact lenses<br>* Commercially available soft contact lenses for daily wear worn in Part A of the study<br>* Other names: ACUVUE OASYS® with HYDRACLEAR® PLUS;Device: Hydrogen peroxide-based cleaning and disinfecting solution<br>* For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study<br>* Other names: CLEAR CARE®;|
| Other: AOHP, then LID018869 (Part A)<br>Senofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. | Device: Lehfilcon A contact lenses<br>* Investigational soft contact lenses for daily wear worn in Part A of the study<br>* Other names: LID018869;Device: Senofilcon A contact lenses<br>* Commercially available soft contact lenses for daily wear worn in Part A of the study<br>* Other names: ACUVUE OASYS® with HYDRACLEAR® PLUS;Device: Hydrogen peroxide-based cleaning and disinfecting solution<br>* For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study<br>* Other names: CLEAR CARE®;|
| Active Comparator: Biofinity (Part B)<br>Comfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. | Device: Comfilcon A contact lenses<br>* Commercially available soft contact lenses for daily wear worn in Part B of the study<br>* Other names: CooperVision® Biofinity®;Device: Hydrogen peroxide-based cleaning and disinfecting solution<br>* For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study<br>* Other names: CLEAR CARE®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Visual Acuity (VA) (Part A) | Distance 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. No formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only. | Day 30, each study lens type | 

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