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OpenTrials
Completed

NCT Number: NCT06317038

To Evaluate the Performance of Total 30 (Lehifilcon A) Contact Lenses in Patients Using Digital Devices for Greater Than 8 Hours Per Day 5 Days Per Week Based on Subjective Reported Data.

To evaluate the performance of Total 30® (lehfilcon A) contact lenses in patients using digital devices for greater than 8 hours per day 5 days per week based on subjective reported data.

Completed

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult patients aged 18-40 of any sex and any race.
  • Reports habitually using digital device usage (phone, Ipad, computer, social media, video streaming) for 8 hours or more per day 5 days per week with plans to continue the habit throughout the study.
  • Wearing contact lenses for at least 13 hours daily 5 days per week.
  • Spherical refractive error between -11.00 D and +6.00D with < -0.75 D of astigmatism.
  • Willing to comply with the protocol instructions.
  • Has read (or has had read to), understood, and signed an Informed Consent.
  • Willing to not use any artificial tears, rewetting drops or dry eye treatments during the study.

Exclusion criteria

  • Active ocular infection or ocular inflammatory disease.
  • Presbyopic or pre-presbyopic that have a measured add power for reading.
  • Current Total 30 contact lens wearer.
  • Anterior basement membrane dystrophy or history of recurrent erosion syndrome or topographical abnormalities that might indicate ectasia or other corneal degenerative conditions.
  • Current or previous diagnosis of dry eye disease; currently using a dry eye treatment including but not limited to artificial tears, rewetting drops or prescription treatments.
  • History of severe / serious ocular pathology or other medical conditions that could result in an inability to safely complete the study.
  • Participation by the patient in any other investigational study within the past 30 days.
  • Unlikely to comply with protocol instructions for any reason (confusion, substance abuse, etc.). The Principal Investigator or the Medical Monitor reserves the right to declare a patient ineligible based on medical evidence that indicates the patient is unsuitable for the study.
  • Inability to utilize Clear Care Cleaning solution.
  • Pregnancy

Treatment and study plan

Total 30 Contact Lens

Device

Patients will be give a contact lens for 1 month

Primary outcomes

  1. Likert question about comfort satisfaction while wearing Total 30 contact lenses on a typical day (> 13 hours of daily wear) after 1 month of wear and heavy digital device usage (>8 hours daily wear).

    Time frame: 1 month

    Likert Questionaire: Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree

Secondary outcomes

  1. Likert responses to insertion comfort and overall vision, and heavy digital device use on a typical day after 1 month of wear.

    Time frame: 1 month

    Likert Questionaire: Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree

  2. Results of subjective ratings of patients using Total 30 lenses and heavy digital device usage with VAS diary questionnaire.

    Time frame: 1 month

    VAS diary: scale 0-100 (0=No Discomfort 100= Maximal Comfort)

  3. Report on total daily wear time and digital device usage.

    Time frame: 1 month

    Survey: Total number of hours

Sponsors and collaborators

Lead sponsor

Tauber Eye Center

Other

Collaborators

  • Alcon Research

Registry information

Official study title

Performance of TOTAL30 (Lehfilcon A) Contact Lenses in Patients Using Digital Devices and 89814415

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 19, 2024
Registry last updated
May 1, 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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