Eye StrainNCT06317038
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.
A study testing Total 30 Contact Lens in people with Eye Strain, run by Tauber Eye Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Strain
- What is being tested?
- Total 30 Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance of TOTAL30 (Lehfilcon A) Contact Lenses in Patients Using Digital Devices and 89814415
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.
- Conditions
- Eye Strain
- Being tested
- Total 30 Contact Lens
- Keywords
- Contact lenses, Digital Devices, Eye Comfort
- Medical subject headings
- Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total 30 Contact LensDevice
Patients will be give a contact lens for 1 month
| Study group | Role | What they receive |
|---|---|---|
| Digital Device uses for 8 hours per day | Other | Observational responses from patients using digital devices for 8 hours per day will be given a monthly Total 30 Contact lens. Receives: Device: Total 30 Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (3)
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
Measured: 1 month
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)
Measured: 1 month
Report on total daily wear time and digital device usage.
Survey: Total number of hours
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start31 Mar 2024
- Primary completion11 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye StrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label Observation
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tauber Eye Center
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Joseph Tauber, Tauber Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317038
- Sponsor's protocol ID
- 89814415
- Status last verified
- Apr 2025
- First submitted
- 12 Mar 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of TOTAL30 (Lehfilcon A) Contact Lenses in Patients Using Digital Devices and 89814415
- ClinicalTrials.gov ID
- NCT06317038
- Acronym / sponsor ID
- 89814415
- Conditions
- Eye Strain
- Keywords
- Contact lenses, Digital Devices, Eye Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Tauber Eye CenterUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 31 Mar 2024 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label Observation
| Arm | Type | Receives |
|---|---|---|
| Digital Device uses for 8 hours per day | Other | Device: Total 30 Contact LensObservational responses from patients using digital devices for 8 hours per day will be given a monthly Total 30 Contact lens. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total 30 Contact LensPatients will be give a contact lens for 1 month | Device | Digital Device uses for 8 hours per day |
Primary outcome
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
3 secondary outcomes
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
Results of subjective ratings of patients using Total 30 lenses and heavy digital device usage with VAS diary questionnaire.
Time frame: 1 month
Report on total daily wear time and digital device usage.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total 30 Contact Lens in people with Eye Strain, run by Tauber Eye Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.