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OpenTrials
Completed

NCT Number: NCT06052046

Total30 for Astigmatism Contact Lenses

Determine if Total30 for Astigmatism contact lenses (CLs) provide a comfortable wearing experience all day. CL discomfort affects most CL wearers with discomfort consistently topping the reasons why established CL wearers drop out of CLs. In fact, studies have consistently found that the frequency of CL dropout is around 20% with this dropout frequency staying relatively stable over the past 20 plus years. This static frequency of CL dropout is surprising since there have been a number of dramatic soft CL innovations during this time frame (e.g., widely available daily disposable CLs, silicone hydrogel CL materials with high oxygen transmissibility, new CL surface coatings).

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kannarr Eye Care, Pittsburg, Kansas, United States

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About this study

A common issues that contact lens (CL) wearers frequently face is that their discomfort symptoms increase 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 for Astigmatism 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 for Astigmatism CLs. These data are not only important for judging the performance of Total30 for Astigmatism 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

  • 18- to 45-year-old
  • Visual acuity 20/20 or better
  • Contact Lens Dry Eye Questionnaire [CLDEQ]-8 scores <10
  • Willing to wear Total30 for Astigmatism CLs
  • Have a smart phone with text messaging capabilities
  • Astigmatism ranging from 0.75 D to 2.50 D in each eye
  • Regularly worn 2 week or monthly CLs within the past 6 months
  • Current CL wearer
  • Glasses prescription that is less than 2 years old
  • Willing to start wearing their CLs between 6:00 AM and 8:00 AM and wear their CLs until 11:00 PM each day text messaging data is collected

Exclusion criteria

  • Current or past hard CL wearers
  • A known systemic health condition that is thought to alter tear film physiology
  • A history of viral eye disease
  • A history of ocular surgery
  • A history of severe ocular trauma
  • Have an active ocular infection or inflammation
  • Currently using isotretinoin-derivatives or ocular medications
  • Currently using rewetting drops or artificial tears
  • Pregnant or breast feeding
  • Willing to discontinue usage of current toric CLs one week prior to the initial visit

Treatment and study plan

TOTAL30 for Astigmatism Contact Lenses

Device

Participants will be refit into TOTAL30 for Astigmatism Contact Lenses and followed for 1 month.

Other names: Lehfilcon A

Primary outcomes

  1. Visual Analog Scale (VAS) Comfort Scores

    Time frame: Change from baseline at 1 month

    A VAS will be used to compare end of day ocular comfort at about 16 hours of contact lens wear (± 50 scale with +50 being best possible comfort and -50 being worst possible comfort).

Sponsors and collaborators

Lead sponsor

Southern College of Optometry

Other

Collaborators

  • Alcon Research

Registry information

Official study title

How Does Total30 for Astigmatism Perform During a Long Day of Wear?

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2023
Registry last updated
Feb 24, 2025

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.

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