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CompletedNCT06317038Updated May 1, 2025

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.

An interventional study of Total 30 Contact Lens in Eye Strain, sponsored by Tauber Eye Center. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-01.

Sponsored by Tauber Eye Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Eye Strain

Browse trials for

Keywords

  • Contact lenses
  • Digital Devices
  • Eye Comfort
03

In context

Asthenopia

67 studies on the registry are indexed under Asthenopia; 10 are open to participants now.

This study's enrollment of 35 is below the median of 56 across 56 interventional studies indexed under Asthenopia.

Browse Asthenopia studies →

Lead sponsor

Tauber Eye Center is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • Willing to not use any artificial tears, rewetting drops or dry eye treatments during the study.

Exclusion criteria

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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Other
    Digital Device uses for 8 hours per day

    Observational responses from patients using digital devices for 8 hours per day will be given a monthly Total 30 Contact lens.

    Device: Total 30 Contact Lens

Interventions

  • DeviceTotal 30 Contact Lens

    Patients will be give a contact lens for 1 month

06

What researchers measure

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).

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

    Time frame: 1 month

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.

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

    Time frame: 1 month

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

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

    Time frame: 1 month

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

    Survey: Total number of hours

    Time frame: 1 month

07

Study locations

1 site
  • Tauber Eye Center
    Kansas City, Missouri 64111, United States
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2024 to primary completion in Nov 2024, 7 months.

Of 31 non-industry interventional studies with no phase under Asthenopia, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 9. This study's 7 months is above that.

Counting every sponsor, half of 38 studies reached it within 3 months; a quarter within 2 and three quarters within 9.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2024
First posted
Mar 19, 2024
StartActual
Mar 31, 2024
Primary completionActual
Nov 11, 2024
CompletionActual
Dec 1, 2024
Last update
May 1, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06317038
Lead sponsor
Tauber Eye Center
Collaborators
Alcon Research
Responsible party
Joseph Tauber (Crystal Remington OD, FAAO, Tauber Eye Center) — Principal investigator
First posted
Mar 19, 2024
Start date
Mar 31, 2024
Primary completion
Nov 11, 2024
Completion
Dec 1, 2024
Last update
May 1, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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