Total30 Sphere Contact Lenses

Key information

Conditions

Contact Lens Complication Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device

Participants will be refit into Total30 Sphere contact lenses and followed for 1 month.

Other names: Lehfilcon A

Primary outcomes

Visual Analog Scale (VAS) Ocular Comfort

Time frame: 1 month

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).

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

Alcon Research

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jan 10, 2022
Registry last updated: Dec 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed