Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to evaluate the overall performance of PRECISION1™ for Astigmatism contact lenses with MyDay® Toric contact lenses.

Detailed Description
-----------------
Subjects will be expected to attend 4 visits and wear study lenses daily for approximately 10 hours per day. On the day prior to the Week 1 Follow-up visit of each crossover period, subjects will be asked to wear the respective study lens for at least 16 hours. The expected duration of subject participation in the study is approximately 3 weeks.

Official Title
-----------------
Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses

Conditions
-----------------
Refractive Errors, Astigmatism

Intervention / Treatment
-----------------
* Device: Verofilcon A toric contact lenses
* Device: Stenfilcon A toric contact lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Successful wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months. Willing to wear study contact lenses for at least 16 hours on the day prior to the Week 1 Follow up visit of each lens type. Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Current/previous wear of PRECISION1 for Astigmatism or MyDay Toric contact lenses. Current wear of spherical contact lenses. Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week). 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: P1fA, then MyDay Toric<br>Verofilcon A toric contact lenses worn first, with stenfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality. | Device: Verofilcon A toric contact lenses<br>* Soft contact lenses for optical correction of astigmatism, used as indicated<br>* Other names: P1fA;Device: Stenfilcon A toric contact lenses<br>* Soft contact lenses for optical correction of astigmatism, used as indicated<br>* Other names: MyDay Toric;|
| Other: MyDay Toric, then P1fA<br>Stenfilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality. | Device: Verofilcon A toric contact lenses<br>* Soft contact lenses for optical correction of astigmatism, used as indicated<br>* Other names: P1fA;Device: Stenfilcon A toric contact lenses<br>* Soft contact lenses for optical correction of astigmatism, used as indicated<br>* Other names: MyDay Toric;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of lenses with axis orientation within ±30 degrees inclusive from the intended axis, 10 minutes after lens insertion | Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis. | Day 1, 10 minutes after lens insertion, each product | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contact lenses, Daily disposable