Contact Lens ComplicationT30FANCT06266728
T30 for Astigmatism in Digital Device Users
A study testing Total30 for Astigmatism Contact Lenses in people with Contact Lens Complication and Astigmatism, run by Southern College of Optometry at 2 sites in United States.
Trial summary
This study aims to determine if Total30 lenses for astigmatism can be successfully fit in participants who are heavy digital device users. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Lens Complication, Astigmatism, Refractive Errors
- What is being tested?
- Total30 for Astigmatism Contact Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Mar 2024to 18 Aug 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 (18- to 40-year-old)
- 0.00 LogMAR visual acuity or better in their habitual CLs or by manifest refraction in both eyes
- Smart phone with text messaging capabilities
- Existing wearers of soft, frequent replacement toric CLs within past 6 months
- Frequent digital device user (e.g., phone, iPad, computer, social media, video streaming, etc.) defined as at least 8 hours of usage per day
- Willing to follow the required wear schedule
Show all 24Show fewer
- Astigmatism ranging from 0.75 D to 2.50 D in each eye
- Willing to wear their CLs at least 13 hours/day
- Exclusion Criteria: Have known systemic health conditions that are thought to alter tear film physiology (e.g., Sjögren's syndrome).
- Have a known history of being diagnosed with dry eye disease
- Have a history of ocular surgery within the past 12 months
- Have a history of severe ocular trauma, active ocular infection or inflammation
- Have a history of viral eye disease
- Currently using isotretinoin-derivatives or ocular medications
- Currently using a dry eye treatment including but not limited to artificial tears
- Currently using rewetting drops daily or occasionally
- If they are pregnant or breast feeding
- Need for spectacle add power of any amount (presbyopic)
- Currently wearing T30fA CLs
- Have a history of wearing hard CLs
- Subjects who show excessive lens oscillation with the T30fA lenses during the fitting process yet show 0.0 logMAR acuity, will be excluded from the study.
- Patients who report unstable vision while wearing their habitual or study CLs (e.g., rotational instability of CLs)
- Willing to not use any artificial tears or dry eye treatments during the study
- Willing to not use rewetting drops during the study
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Coldwater VIsion Center
Coldwater, Mississippi, 38618
Kannar Eye Care
Pittsburg, Kansas, 66762
About this study
Official title: Performance of Total30 for Astigmatism in Digital Device Users
This study aims to determine if Total30 lenses for astigmatism can be successfully fit in participants who are heavy digital device users.
Read the detailed description
Extensive computer use is no longer an employment-specific challenge. Use of digital devices in work, home, and leisure settings is now the norm, and it is now socially expected. While the introduction of high-powered computers and digital devices have greatly improved many aspects of modern life, the pervasive use of digital devices has caused some patients to develop a condition known as Digital Eye Strain (DES). DES has been reported to be as high as 93% the population depending upon how the condition is defined, and its severity has been found to increase with increased digital device time. DES is a condition where patients experience symptoms such as glare, accommodative dysfunction, defocus, fatigue, discomfort, and dryness from digital device use, and these dry eye symptoms may also result in decreased quality of life. While dryness symptoms in DES are likely multifactorial (e.g., contact lens use, systemic disease status), much of the dryness symptoms in DES are probably due to tear film evaporation secondary to having a reduced number of blinks per minute while using digital devices.
Contact lens (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). CL discomfort and dropout could be affected by significant time spent on digital devices and DES. Maintaining ocular comfort with satisfactory CL performance (comfort, lack of dryness, and overall good vision) is key to overall success. This could be especially important in patients who wear astigmatic CLs, yet the community currently lacks data on this topic.
- Conditions
- Contact Lens Complication, Astigmatism, Refractive Errors
- Being tested
- Total30 for Astigmatism Contact Lenses
- Keywords
- Total30 for astigmatism, Comfort, Dryness, Visual Analog Scale, Contact Lens
- Medical subject headings
- Astigmatism, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total30 for Astigmatism Contact LensesDevice
Also called Lehfilcon A
Participants must be refit into Total30 for Astigmatism Contact Lenses and wear them over the course of this one month study.
| Study group | Role | What they receive |
|---|---|---|
| Total 30 for astigmatism contact lenses | Experimental | Total30 for Astigmatism Monthly Replacement Contact Lenses Receives: Device: Total30 for Astigmatism Contact Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Comfort Scores
Participants will receive text message surveys on which they will record the comfort of their lenses throughout various points in the day, during different periods of the 1 month study. Scores will be recorded on a scale +/- 50 with +50 being the highest level of comfort and -50 being uncomfortable.
Measured: Baseline to 1 month of Contact lens wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Mar 2024
- Primary completion15 Aug 2024
- Study completion18 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens ComplicationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This prospective, one-month, three-visit study will refit all participants into TOTAL30 for Astigmatism contact lenses.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern College of Optometry
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266728
- Sponsor's protocol ID
- IRB00006733
- Acronym
- T30FA
- Status last verified
- Apr 2024
- First submitted
- 12 Feb 2024
- Last updated
- 24 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Total30 for Astigmatism in Digital Device Users
- ClinicalTrials.gov ID
- NCT06266728
- Acronym / sponsor ID
- T30FA / IRB00006733
- Conditions
- Contact Lens Complication, Astigmatism, Refractive Errors
- Keywords
- Total30 for astigmatism, Comfort, Dryness, Visual Analog Scale, Contact Lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Southern College of OptometryUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 18 Aug 2024 (actual)
- First posted
- 20 Feb 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.
This study aims to determine if Total30 lenses for astigmatism can be successfully fit in participants who are heavy digital device users.
Detailed description
Extensive computer use is no longer an employment-specific challenge. Use of digital devices in work, home, and leisure settings is now the norm, and it is now socially expected. While the introduction of high-powered computers and digital devices have greatly improved many aspects of modern life, the pervasive use of digital devices has caused some patients to develop a condition known as Digital Eye Strain (DES). DES has been reported to be as high as 93% the population depending upon how the condition is defined, and its severity has been found to increase with increased digital device time. DES is a condition where patients experience symptoms such as glare, accommodative dysfunction, defocus, fatigue, discomfort, and dryness from digital device use, and these dry eye symptoms may also result in decreased quality of life. While dryness symptoms in DES are likely multifactorial (e.g., contact lens use, systemic disease status), much of the dryness symptoms in DES are probably due to tear film evaporation secondary to having a reduced number of blinks per minute while using digital devices.
Contact lens (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). CL discomfort and dropout could be affected by significant time spent on digital devices and DES. Maintaining ocular comfort with satisfactory CL performance (comfort, lack of dryness, and overall good vision) is key to overall success. This could be especially important in patients who wear astigmatic CLs, yet the community currently lacks data on this topic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This prospective, one-month, three-visit study will refit all participants into TOTAL30 for Astigmatism contact lenses.
| Arm | Type | Receives |
|---|---|---|
| Total 30 for astigmatism contact lenses | Experimental | Device: Total30 for Astigmatism Contact LensesTotal30 for Astigmatism Monthly Replacement Contact Lenses |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- Adult (18- to 40-year-old)
- 0.00 LogMAR visual acuity or better in their habitual CLs or by manifest refraction in both eyes
- Smart phone with text messaging capabilities
- Existing wearers of soft, frequent replacement toric CLs within past 6 months
- Frequent digital device user (e.g., phone, iPad, computer, social media, video streaming, etc.) defined as at least 8 hours of usage per day
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Total30 for Astigmatism Contact LensesAlso: Lehfilcon AParticipants must be refit into Total30 for Astigmatism Contact Lenses and wear them over the course of this one month study. | Device | Total 30 for astigmatism contact lenses |
Primary outcome
Visual Analog Scale (VAS) Comfort Scores
Time frame: Baseline to 1 month of Contact lens wear
Participants will receive text message surveys on which they will record the comfort of their lenses throughout various points in the day, during different periods of the 1 month study. Scores will be recorded on a scale +/- 50 with +50 being the highest level of comfort and -50 being uncomfortable.
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 24 Feb 2025.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total30 for Astigmatism Contact Lenses in people with Contact Lens Complication and Astigmatism, run by Southern College of Optometry at 2 sites 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 24 inclusion and 0 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 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Visual Analog Scale (VAS) Comfort Scores (time frame: Baseline to 1 month of Contact lens wear). 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 24 Feb 2025.