Comparison of Two Daily Disposable Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare the clinical performance of the new DAILIES® AquaComfort PLUS® FreshTech (DACP FreshTech) contact lenses to an already marketed daily disposable contact lens, DAILIES® AquaComfort PLUS® (DACP).

Detailed Description
-----------------
Subjects attended 4 scheduled visits for an expected duration of participation of 3 weeks.

Official Title
-----------------
Comparison of Two Daily Disposable Lenses

Conditions
-----------------
Myopia, Refractive Ametropia

Intervention / Treatment
-----------------
* Device: DACP FreshTech contact lenses
* Device: DACP contact lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 3 months of soft contact lens wearing experience; Wears habitual lenses at least 5 days per week and at least 8 hours per day; Uses digital devices (computer, tablet, and/or smart phone) for an average of 4 hours per day; Experiences eye fatigue at least once per week attributable to digital device use with habitual lenses; Is willing to NOT use rewetting/lubricating drops during the period of study product exposure; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Routinely sleeps in contact lenses; Known pregnancy at time of enrollment; Binocular vision issues or issues of eye alignment; Any eye infection, inflammation, disease or abnormality that contraindicates contact lens wear; Use of medications as specified in the protocol; Ocular surgery within the past 12 months; Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DACP FreshTech, then DACP<br>DACP FreshTech contact lenses worn first, followed by DACP contact lenses, as randomized. Each product was worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day. | Device: DACP FreshTech contact lenses<br>* Nelfilcon A soft contact lenses with a modified lens design<br>* Other names: DAILIES® AquaComfort PLUS® FreshTech;Device: DACP contact lenses<br>* Nelfilcon A soft contact lenses<br>* Other names: DAILIES® AquaComfort PLUS®;|
| Other: DACP, then DACP FreshTech<br>DACP contact lenses worn first, followed by DACP FreshTech contact lenses, as randomized.. Each product was worn in both eyes for approximately 8 hours per day, for 1 week with a new pair of lenses worn each day. | Device: DACP FreshTech contact lenses<br>* Nelfilcon A soft contact lenses with a modified lens design<br>* Other names: DAILIES® AquaComfort PLUS® FreshTech;Device: DACP contact lenses<br>* Nelfilcon A soft contact lenses<br>* Other names: DAILIES® AquaComfort PLUS®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Distance Visual Acuity (VA) With Study Lenses | VA was assessed at a distance of 4 meters using a letter chart and 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 a lower logMAR value indicating better visual acuity. | Week 1, each product | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eye strain, eye fatigue