NCT05183022

Total30 Sphere Contact Lenses

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Contact Lens Complication
• Dry Eye

Interventions

Type	Name	Description
DEVICE	Total30 Sphere Contact Lenses	Participants will be refit into Total30 Sphere contact lenses and followed for 1 month.

Timeline

• Start date: 2022-01-03
• Primary completion: 2022-07-20
• Completion: 2022-07-20
• First posted: 2022-01-10
• Last updated: 2022-12-16
• Results posted: 2022-12-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study