Contact Lens ComplicationNCT06052046
Total30 for Astigmatism Contact Lenses
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
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. Read more about this study
- Who is it for?
- Ages 18 to 45 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 Oct 2023to 1 Jun 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Coldwater VIsion Center
Coldwater, Mississippi, 38618
Kannarr Eye Care
Pittsburg, Kansas, 66762
About this study
Official title: How Does Total30 for Astigmatism Perform During a Long Day of Wear?
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).
Read the detailed description
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.
- 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 will be refit into TOTAL30 for Astigmatism Contact Lenses and followed for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| Total30 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
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).
Measured: Change from baseline at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start15 Oct 2023
- Primary completion11 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- NCT06052046
- Sponsor's protocol ID
- IRB-00006733
- Status last verified
- Nov 2023
- First submitted
- 18 Sep 2023
- Last updated
- 24 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Summary data will be published in a peer-reviewed manuscript.
Publications
Lievens C, Perkins A, Rayborn E, Wang Y, Franklin Q, May K, Kannarr S, Bromley M, Pucker AD. Real-Time Changes in the Comfort of a Toric, Monthly, Soft Contact Lens Over a Long Day of Wear. Clin Optom (Auckl). 2024 Dec 17;16:317-325. doi: 10.2147/OPTO.S490934. eCollection 2024.
PubMed 39713278
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
- How Does Total30 for Astigmatism Perform During a Long Day of Wear?
- ClinicalTrials.gov ID
- NCT06052046
- Acronym / sponsor ID
- IRB-00006733
- 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 Oct 2023 (actual)
- Primary completion
- 11 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 25 Sep 2023 (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.
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).
Detailed description
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.
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 |
|---|---|---|
| Total30 for Astigmatism Contact Lenses | Experimental | Device: TOTAL30 for Astigmatism Contact LensesTOTAL30 for Astigmatism Monthly Replacement Contact Lenses |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 will be refit into TOTAL30 for Astigmatism Contact Lenses and followed for 1 month. | Device | Total30 for Astigmatism Contact Lenses |
Primary outcome
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).
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.
- Derived from this study: PubMed 39713278Lievens C, Perkins A, Rayborn E, Wang Y, Franklin Q, May K, Kannarr S, Bromley M, Pucker AD. Real-Time Changes in the Comfort of a Toric, Monthly, Soft Contact Lens Over a Long Day of Wear. Clin Optom (Auckl). 2024 Dec 17;16:317-325. doi: 10.2147/OPTO.S490934. eCollection 2024.
- Individual participant dataSharing planned: No. Summary data will be published in a peer-reviewed manuscript.
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 10 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 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: Change from baseline at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06052046, which also lists 1 linked publication.
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.