Clinical Comparison of Two Daily Disposable Toric Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial was to compare the performance of two contact lenses commercially available for people with astigmatism.

Detailed Description
-----------------
This trial compared the performance of two commercialized daily disposable contact lenses in Germany.

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

Conditions
-----------------
Myopia, Astigmatism

Intervention / Treatment
-----------------
* Device: nelfilcon A contact lens
* Device: etafilcon A contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sign written informed consent. Germany: Be of legal age. Current monthly or weekly toric soft lens wearer able to be fit in both eyes with soft toric lenses in the study parameters. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks. Pre-existing ocular irritation that would preclude contact lens fitting. Currently enrolled in an ophthalmic clinical trial. Wears contact lenses overnight while sleeping. Habitual daily disposable contact lens wearer. Monovision correction during the study. Other protocol-defined 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: nelfilcon A / etafilcon A<br>Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. | Device: nelfilcon A contact lens<br>* Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear.<br>* Other names: Focus® DAILIES® Toric;Device: etafilcon A contact lens<br>* Commercially marketed, etafilcon A, toric, soft contact lens for daily disposable wear.<br>* Other names: 1-DAY ACUVUE® MOIST® FOR ASTIGMATISM;|
| Other: etafilcon A / nelfilcon A<br>Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. | Device: nelfilcon A contact lens<br>* Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear.<br>* Other names: Focus® DAILIES® Toric;Device: etafilcon A contact lens<br>* Commercially marketed, etafilcon A, toric, soft contact lens for daily disposable wear.<br>* Other names: 1-DAY ACUVUE® MOIST® FOR ASTIGMATISM;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Vision | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent. | 1 week, replacing lenses daily | 
| Overall Comfort | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent. | 1 week, replacing lenses daily | 
| Overall Handling | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy. | 1 week, replacing lenses daily | 
| Overall Satisfaction | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent. | 1 week, replacing lenses daily | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Selecting Final Lens Power | As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy. | Day 0 |