Tear Film Stability of DAILIES® AquaComfort Plus® Contact Lenses vs. MyDay® Daily Disposable Contact Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate tear film stability of DAILIES® AquaComfort Plus® (DACP) compared to MyDay® after 12 hours of lens wear.

Official Title
-----------------
Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection

Conditions
-----------------
Refractive Error

Intervention / Treatment
-----------------
* Device: Nelfilcon A contact lenses
* Device: Stenfilcon A contact lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must sign an Informed Consent form; Adapted, current soft contact lens wearer; Required contact lens prescription within the power range specified in the protocol (+6.00 to -10.00 diopters (D)); Cylinder ≤ -1.00 D in both eyes at Visit 1; Vision correctable to 0.1 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye at distance with pre-study lenses at Visit 1; Willing to wear study lenses up to 12 hours and attend all study visits; Able to be successfully fitted with study lenses; Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear; Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator; Use of artificial tears and rewetting drops during the study; Monocular (only 1 eye with functional vision) or fit with only 1 lens; Any abnormal ocular condition observed during Visit 1; History of herpetic keratitis, ocular surgery, or irregular cornea; Pregnant or lactating; Participation in any clinical study within 30 days of Visit 1; Current MyDay® or DAILIES® AquaComfort Plus® lens wearer; Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DACP/MyDay<br>Nelfilcon A contact lenses worn in Period 1, with stenfilcon A contact lenses in Period 2. Each product worn bilaterally for 12 hours over 1 day. | Device: Nelfilcon A contact lenses<br> <br> * Other names: DACP;Device: Stenfilcon A contact lenses<br> <br> * Other names: MyDay®;|
| Other: MyDay/DACP<br>Stenfilcon A contact lenses worn in Period 1, with nelfilcon A contact lenses in Period 2. Each product worn bilaterally for 12 hours over 1 day. | Device: Nelfilcon A contact lenses<br> <br> * Other names: DACP;Device: Stenfilcon A contact lenses<br> <br> * Other names: MyDay®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear | The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The time to 15% destabilization of the tear film was calculated. A longer time indicates a more stable tear film. The right eye was evaluated. | Day 1, Hour 12, each period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear | The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The slope of the regression line (distorted areas vs. time) was calculated. A slower speed (higher number) indicates a more stable tear film. The right eye was evaluated. | Hour 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DACP, DAILIES® AquaComfort Plus, Tear film stability, NIK-BUT