Clinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to evaluate DAILIES TOTAL1® Multifocal (DT1MF) contact lenses compared to 1-DAY ACUVUE® Moist® Multifocal (AMMF) contact lenses for investigator-graded lens centration in a Japanese population.

Detailed Description
-----------------
Subjects will be randomly assigned to one of two sequences of investigational product wear ((DT1MF→AMMF, AMMF→DT1MF). Each product will be worn in both eyes for at least 11 days.

Official Title
-----------------
Clinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population

Conditions
-----------------
Refractive Error, Presbyopia

Intervention / Treatment
-----------------
* Device: Delefilcon A multifocal contact lenses
* Device: Etafilcon A multifocal contact lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sign informed consent Habitually wear multifocal soft/ silicone hydrogel contact lenses Require a near spectacle ADD of +0.50 diopters (D) to +2.50D (inclusive) Correctable to 20/30 Snellen or 0.2 logarithm minimum angle of resolution (logMAR) or better in each eye at distance Willing to wear contact lenses and attend all study visits Exclusion Criteria: Currently wearing DAILIES TOTAL 1® Multifocal or 1-DAY ACUVUE® Moist® Multifocal contact lenses Any eye condition that would make contact lens wear unadvisable Any use of medication that would make contact lens wear unadvisable Prior refractive surgery

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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: DT1MF, then AMMF<br>Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days. | Device: Delefilcon A multifocal contact lenses<br>* Silicone hydrogel multifocal contact lenses for daily disposable wear<br>* Other names: DAILIES TOTAL 1® Multifocal;Device: Etafilcon A multifocal contact lenses<br>* Hydrogel multifocal contact lenses for daily disposable wear<br>* Other names: 1-DAY ACUVUE® Moist® Multifocal;|
| Other: AMMF, then DT1MF<br>Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days. | Device: Delefilcon A multifocal contact lenses<br>* Silicone hydrogel multifocal contact lenses for daily disposable wear<br>* Other names: DAILIES TOTAL 1® Multifocal;Device: Etafilcon A multifocal contact lenses<br>* Hydrogel multifocal contact lenses for daily disposable wear<br>* Other names: 1-DAY ACUVUE® Moist® Multifocal;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Investigator-graded Lens Centration of Optimal | Lens centration was assessed by slit-lamp microscopy and graded on a 5-point scale, where 0=Optimal/Centered and 4=Severe decentration (with corneal exposure). One target eye was randomly selected for analysis. | Day 14, each product | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contact lenses, lens centration, multifocal