Total30 Sphere Contact Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs.

Detailed Description
-----------------
Contact lens (CL) wearers frequently face eye discomfort symptoms, especially towards the end of the wear day. This burdensome discomfort can unfortunately cause patients to remove their CLs before their desired wear time. While comfortable wear times vary from patient to patient, Terry et al. has suggested that patients should be able to comfortably wear their CLs for at least 12 hours per day for at least 6 days per week. Nevertheless, the literature currently lacks sufficient data to comment fully on the full day wear experience, which for many patients may be 16 or more hours per day, especially if they have demanding careers. One CL that has the potential to allow for all day comfort is the Total30 Sphere CLs, which is a new water gradient, monthly CL aimed at delivering all day comfort and visual performance. Thus, the purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs. These data are not only important for judging the performance of Total30 Sphere CLs, but they will provide some of the first insights into the full day CL wearing experience over one month.

Official Title
-----------------
Do Total 30 Sphere Contact Lenses Provide a Comfortable Wearing Experience All Day?

Conditions
-----------------
Contact Lens Complication, Dry Eye

Intervention / Treatment
-----------------
* Device: Total30 Sphere Contact Lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current contact lens wearers who have 20/20 visual acuity or better Minimally symptomatic as based upon Contact Lens Dry Eye Questionnaire scores (≤10) Astigmatism better than or equal to 0.50 D in each eye Must have regularly worn 2 week or monthly contact lenses within the past 6 months Must provide a glasses prescription that is is less than 3 years old Willing to start wearing their contact lenses between 6:00 AM and 8:00 AM and wear their contact lenses until 11:00 PM each day Exclusion Criteria: Past or Current hard CL use Any known systemic health conditions that are thought to alter tear film physiology History of viral eye disease History of ocular surgery History of severe ocular trauma Active ocular infection or inflammation Currently using isotretinoin-derivatives Currently using ocular medications Currently using rewetting drops or artificial tear Pregnant or breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This prospective, one-month, three-visit study will refit all participants into Total30 Sphere contact lenses.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total30 Sphere Contact Lenses<br>All qualified participants will be refit into Total30 Sphere contact lenses. | Device: Total30 Sphere Contact Lenses<br>* Participants will be refit into Total30 Sphere contact lenses and followed for 1 month.<br>* Other names: Lehfilcon A;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) Ocular Comfort | A visual analog scale (VAS) was used to compare end of day ocular comfort at 16 hours of contact lens wear over the 1 month study (0 to 100 scale with 100 being best). | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total30 Sphere Contact Lenses; Comfort; Dryness; Visual Analog Scale Scores