Total30 Sphere Contact Lenses
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Details and patient eligibility
About
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.
Full 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.
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
48 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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