Two Daily Disposable Contact Lenses in Symptomatic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the performance of DAILIES TOTAL1® and ACUVUE OASYS® 1-DAY and with respect to visual acuity in a symptomatic study population of monthly or bi-weekly replacement lens wearers.

Official Title
-----------------
Two Daily Disposable Contact Lenses in Symptomatic Patients

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Delefilcon A contact lenses
* Device: Senofilcon A contact lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to understand and must sign an IRB-approved informed consent form; Soft contact lens wearers in both eyes during the past 3 months; Best-corrected visual acuity (BCVA) 20/25 or better in each eye; Willing to wear study lenses at least 3 days per week and at least 8 hours per day; Willing to stop wearing habitual contact lenses for the duration of study participation. Exclusion Criteria: Infection, inflammation, abnormality, condition, disease, surgery, or use of medications, as specified in the protocol; Intolerance, hypersensitivity, or allergy to any component of the study products; 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; Monocular (only one eye with functional vision).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TOTAL1<br>Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality | Device: Delefilcon A contact lenses<br>* Water Gradient silicon hydrogel daily disposable contact lenses<br>* Other names: DAILIES TOTAL1® (DT1);|
| Active Comparator: 1-DAY<br>Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality | Device: Senofilcon A contact lenses<br>* Silicon hydrogel daily disposable contact lenses with HydraLuxe™ Technology<br>* Other names: ACUVUE OASYS® 1-DAY;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Corrected Distance Visual Acuity (VA) | Monocular (each eye) corrected (with spectacles or other visual corrective devices) VA was performed under dimmed room illumination using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at distance. VA was reported in logMAR (logarithm of the minimum angle of resolution), with a lower logMAR indicating better visual acuity. No inferential hypotheses was planned for this endpoint. | Week 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Symptomatic