Clinical Assessment of Two Daily Wear Reusable Soft Silicone Hydrogel Contact Lenses

Study Overview
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Brief Summary
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The overall objective of this clinical study is to describe the clinical performance of the TOTAL30® soft contact lens compared to the ACUVUE® OASYS® with HYDRACLEAR PLUS (AOHP) soft contact lens in a daily wear modality.

Detailed Description
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Subjects will be expected to attend 3 visits and wear the study contact lenses at least 5 days per week and at least 8 hours per day. On Visits 2 and 3, subjects will be expected to wear the study lenses at least 6 hours prior to the study visit. The expected total duration of subject participation in the study will be approximately 1.5 months. This study will be conducted in the United Kingdom (UK).

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

Conditions
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Refractive Errors

Intervention / Treatment
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* Device: Lehfilcon A contact lenses
* Device: Senofilcon A contact lenses
* Device: AOSEPT PLUS with HydraGlyde


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Currently wearing any commercial spherical soft contact lenses with at least 3 months wearing experience. Willing to wear the study lenses for a minimum of 5 days per week and 8 hours per day. Willing to NOT use rewetting/lubricating drops at any time during the study. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Participation in a clinical trial within the previous 14 days or currently enrolled in any clinical trial. Habitual AOHP contact lens wearers (in the past 3 months). Monovision wear during the study. 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TOTAL30, then AOHP<br>Lehfilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. The lehfilcon A contact lenses will be worn for approximately 28 days. The senofilcon A contact lenses will be worn for approximately 14 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection. | Device: Lehfilcon A contact lenses<br>* CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use<br>* Other names: TOTAL30®;Device: Senofilcon A contact lenses<br>* CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use<br>* Other names: AOHP;Device: AOSEPT PLUS with HydraGlyde<br>* Hydrogen peroxide-based cleaning and disinfecting solution<br>* Other names: AOSEPT® PLUS with HYDRAGLYDE®;|
| Other: AOHP, then TOTAL30<br>Senofilcon A contact lenses worn first, with lehfilcon A contact lenses worn second, as randomized. The senofilcon A contact lenses will be worn for approximately 14 days. The lehfilcon A contact lenses will be worn for approximately 28 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection. | Device: Lehfilcon A contact lenses<br>* CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use<br>* Other names: TOTAL30®;Device: Senofilcon A contact lenses<br>* CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use<br>* Other names: AOHP;Device: AOSEPT PLUS with HydraGlyde<br>* Hydrogen peroxide-based cleaning and disinfecting solution<br>* Other names: AOSEPT® PLUS with HYDRAGLYDE®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance VA (logMAR) With Study Lenses | Distance visual acuity (VA) was assessed for each eye individually with study lenses in place using letter charts. 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 lower logMAR values indicating better visual acuity. The follow-up visit for TOTAL 30 occurred approximately 28 days after the baseline visit. The follow-up visit for AOHP occurred approximately 14 days after the baseline visit. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed. | Dispense (Day 0) and Follow-Up (Day 28 for TOTAL30, Day 14 for AOHP) (each wear period) | 

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