Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses (Study 2)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the subjective performance of two daily disposable contact lenses with respect to comfort and handling.

Official Title
-----------------
Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses

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

Intervention / Treatment
-----------------
* Device: Nelfilcon A contact lens
* Device: UltraFilcon B contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adapted soft contact lens wearer; Spherical distance contact lens prescription between -1.00 and -6.00 diopter (inclusive); Spectacle cylinder ≤0.75 diopter in the least astigmatic eye, ≤1.00 diopter in the other; Correctable to 6/9 (20/30) in both eyes; Read, understand, and sign the informed consent; Willing to comply with the wear schedule; Willing to comply with the study visit schedule; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any active corneal infection, injury or inflammation; Systemic or ocular allergies which might interfere with contact lens wear; Systemic or ocular disease which might interfere with contact lens wear; Strabismus or amblyopia; Corneal refractive surgery and any anterior segment surgery; Use of systemic/topical medication contraindicating contact lens wear; Use of gas permeable contact lenses within 1 month preceding the study; Participation in any concurrent clinical trial or in the last 30 days; Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Nelfilcon A/UltraFilcon B<br>Nelfilcon A contact lenses, followed by UltraFilcon B contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality. | Device: Nelfilcon A contact lens<br>* Soft contact lens CE-marked for daily disposable wear.<br>* Other names: DAILIES® AquaComfort Plus®;Device: UltraFilcon B contact lens<br>* Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Private-label versions may be used.<br>* Other names: Procornea BYO Air Daily;|
| Other: UltraFilcon B/Nelfilcon A<br>UltraFilcon B contact lenses, followed by Nelfilcon A contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality. | Device: Nelfilcon A contact lens<br>* Soft contact lens CE-marked for daily disposable wear.<br>* Other names: DAILIES® AquaComfort Plus®;Device: UltraFilcon B contact lens<br>* Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Private-label versions may be used.<br>* Other names: Procornea BYO Air Daily;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial comfort | Initial Comfort (within 10-15 minutes of lens insertion) will be assessed bilaterally by the participant at time of dispense. Initial Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful). | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End of Day Comfort | End of Day Comfort will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. End of Day Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful). | Day 7 | 
| Overall Comfort | Overall Comfort will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. Overall Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful). | Day 7 | 
| Overall Handling at Time of Removal | Overall Handling at Time of Removal will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. Overall Handling at Time of Removal will be graded on a 1-10 scale (10=excellent, very easy; 1=unmanageable). | Day 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contact lenses, daily disposable contact lenses, silicone hydrogel, contact lens comfort, near-sighted