Clinical Evaluation of MyDay™ and 1-DAY ACUVUE® TruEye®

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the functional vision of 2 daily disposable silicone hydrogel contact lenses using Time Controlled Visual Acuity (TCVA) measurements at high luminance and high contrast after 10+/-3 days of wear post 3 hour exposure to a reduced humidity environment.

Detailed Description
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After randomization, participants attended a baseline visit to include a 3 hour exposure to reduced humidity environment. The participant's habitual lenses were worn for the baseline visit.

Official Title
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Clinical Evaluation of MyDay™ Daily Disposable Silicone Hydrogel Contact Lenses

Conditions
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Refractive Error

Intervention / Treatment
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* Device: Stenfilcon A contact lenses
* Device: Narafilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must sign informed consent form. Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months. Willing to wear lenses every day or at least 5 days per week 6 hours per day. Willing to discontinue artificial tears and rewetting drops usage on the days of study visits. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Monocular (only 1 eye with functional vision) or fit with only 1 lens. Pregnant or lactating. Current MyDay™ or 1DAY ACUVUE® TruEye® lens wearer. Any abnormal ocular condition as specified in the protocol. 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: MyDay, then 1DAVTE<br>Stenfilcon A contact lenses, followed by narafilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality. | Device: Stenfilcon A contact lenses<br>* Contact lenses worn during Period 1 or 2, as randomized<br>* Other names: MyDay™;Device: Narafilcon A contact lenses<br>* Contact lenses worn during Period 1 or 2, as randomized<br>* Other names: 1-DAY ACUVUE® TruEye®;|
| Other: 1DAVTE, then MyDay<br>Narafilcon A contact lenses, followed by stenfilcon A contact lenses. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality. | Device: Stenfilcon A contact lenses<br>* Contact lenses worn during Period 1 or 2, as randomized<br>* Other names: MyDay™;Device: Narafilcon A contact lenses<br>* Contact lenses worn during Period 1 or 2, as randomized<br>* Other names: 1-DAY ACUVUE® TruEye®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10 | High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis. | Day 10, each product | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10 | High contrast TCVA was assessed after 3 hours exposure to normal environment and prior to exposure to reduced humidity environment. Both eyes contributed to the analysis. | Day 10, each product | 

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