Clinical trial NCT05183022: Total30 Sphere Contact Lenses
Official title: Do Total 30 Sphere Contact Lenses Provide a Comfortable Wearing Experience All Day?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Complication
Dry Eye
Keywords: Total30 Sphere Contact Lenses; Comfort; Dryness; Visual Analog Scale Scores
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2022-01-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This prospective, one-month, three-visit study will refit all participants into Total30 Sphere contact lenses.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analog Scale (VAS) Ocular Comfort
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Andrew D Pucker, OD, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: