Visual Assessment of DAILIES® AquaComfort Plus® for Astigmatism as Compared to 1-DAY ACUVUE® MOIST® for Astigmatism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate functional vision associated with rotational stability at blink of DAILIES® AquaComfort Plus® Toric (DACP T) compared to 1-DAY ACUVUE® MOIST® for Astigmatism (1DAM A).

Official Title
-----------------
DAILIES® AquaComfort Plus® Toric - Comparative Assessment of Visual and Mechanical Performance

Conditions
-----------------
Astigmatism

Intervention / Treatment
-----------------
* Device: Nelfilcon A toric contact lenses
* Device: Etafilcon A toric contact lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must sign an Informed Consent document; Wear toric soft contact lenses within the protocol-specified range; Cylinder equal or higher than -0.75 diopters (D) in both eyes; Have an acceptable fit with both study contact lenses; Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, every day, if possible; Best corrected visual acuity (BCVA) of 20/30 Snellen; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Any ocular infection, inflammation, abnormality, or disease that would contraindicate contact lens wear; Use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator; Monocular (only 1 eye with functional vision) or fit with only 1 lens; Require presbyopic correction; Any ocular condition observed during examination at the enrollment visit; History of herpetic keratitis, ocular surgery or irregular cornea; Pregnant or lactating; Participation in any clinical trial within 30 days of the enrollment visit; Currently wearing Focus® DAILIES® Toric or 1-DAY ACUVUE® MOIST® for Astigmatism; Other protocol-specified exclusion criteria may apply.

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DACP T, Then 1DAM A<br>Nelfilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days. | Device: Nelfilcon A toric contact lenses<br> <br> * Other names: DAILIES® AQUACOMFORT PLUS® TORIC;Device: Etafilcon A toric contact lenses<br> <br> * Other names: 1-DAY ACUVUE® MOIST® for Astigmatism;|
| Other: 1DAM A, Then DACP T<br>Etafilcon A toric contact lenses worn first, with nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days. | Device: Nelfilcon A toric contact lenses<br> <br> * Other names: DAILIES® AQUACOMFORT PLUS® TORIC;Device: Etafilcon A toric contact lenses<br> <br> * Other names: 1-DAY ACUVUE® MOIST® for Astigmatism;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Contrast Time Controlled Visual Acuity (TCVA) at Day 10 | 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 |
| --- | --- | --- |
| Lens Oscillation at Blink at Day 10 | Lens oscillation (rotational stability of the lens on the eye) at blink was video-recorded. Digital images were used to measure the rotational characteristics of the lenses and objectively measure the amplitude of the lens oscillation. A higher value indicates greater lens movement on the eye. This outcome measure was collected at one site only. | Day 10, each product | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DACP Toric, DAILIES® AquaComfort Plus®, Astigmatism, Toric