Contact LensesNCT07586982
Clinical Performance of Verofilcon A Toric Contact Lenses
A study testing Total 30 multi foric contact lenses in people with Contact Lenses and Presbyopia, run by Southern College of Optometry at 1 site in United States.
Trial summary
The goal of this clinical trial is to [primary purpose: is to determine if Total30 Multi focal toric conntact lensesare comfortable and the willigness for those who have previously worn reusable toric contact lenses are willing to stay in Total30 MFT after 1 month of wear during the duration of the study. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Lenses, Presbyopia
- What is being tested?
- Total 30 multi foric contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2026to Sep 2026
- Phase
- Interventional
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
- Adults, ≥40-year-old, CL wearers with best-corrected 20/20 distance visual acuity or better.
- Requiring +0.75 ADD or more at standard near distance of 40 cm.
- Participants will be required to have worn reusable silicone hydrogel toric CLs in the past year and still at a minimum wearing the CLs occasionally without having significant discomfort or dryness.
- All participants will be required to have a CLDEQ-8 score <12.
- Participants will be required to be able to wear Total 30MFT CLs (presbyopic plus astigmatism both ≥0.75D OD and OS).
- Astigmatism ranging from 0.75 D to 2.50 D in each eye.
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- Participants will be required to wear the study CLs for ≥13 hours each day with no overnight wear.
- Willing to wear study CLs for ≥16 hours on the Day 1 (1st full day), Day 14, and Day 29 when responses will be collected via text message.
- Participants will be willing to wear the CL every day of the week.
- Participants will be required to provide a glasses prescription that is less than 3 years old.
- Visual acuity with habitual reusable silicone hydrogel toric CLs is 20/25 or better in each eye.
Who cannot join
- Have worn Total30 MFT in the past
- Are past rigid CL wearers
- Are currently wearing monovision CLs
- Have a history of being diagnosed with dry eye or ocular allergies
- Have known systemic health conditions that are thought to alter tear film physiology
- Have a history of viral eye disease
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- Have a history of ocular surgery
- Have a history of severe ocular trauma
- Have a history of corneal dystrophies or degenerations
- Have active ocular infection or inflammation
- Are currently using isotretinoin-derivatives or ocular medications
- Are pregnant or breast feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Southern College of Optometry
Memphis, Tennessee, 38104
Chris Lievens, OD, 9014815699, clievens@sco.edu
About this study
Official title: Clinical Performance of Verofilcon A Toric Contact Lenses in Satisfied Wearers of Senofilcon A Toric Contact Lenses With Blue Light Filtration
The goal of this clinical trial is to [primary purpose: is to determine if Total30 Multi focal toric conntact lensesare comfortable and the willigness for those who have previously worn reusable toric contact lenses are willing to stay in Total30 MFT after 1 month of wear during the duration of the study. Healthy previous reusable toric contact lens weareres will be refit into total30 MFT contact lenses and will be asked to gauge their comfort while wearing the lenses. Healthy adult participants who are presybyopic between the ages of 18-40 can participant, sex and gender are not disqualifiers unless the participant is pregnant or breast feeding. The main question[s] it aims to answer [is/are]
[primary hypothesis or outcome measure 1Proportions of toric CL wearers who have positive visual acuity scores in comfort and vision after one month of wear.
[primary hypothesis or outcome measure 2]? Contact lens dry eye-8 scores will be less than 12 indicating high levels of comfort after one month of wear.
Read the detailed description
TOTAL30® Multifocal Toric contact lenses (CLs) are a 1-month, silicone hydrogel (lehfilcon A), studies have likewise found the lehfilcon A material to provides a comfortable wearing experience for the full life of the CL and for the full CL wear day.1 While initial TOTAL30 data are promising, the literature currently lacks data directly related to the Total30 MFT design and a targeted study aimed at evaluating how Total30 MFT performs with regards to overall comfort, vision, and satisfaction for those who are previous reusable toric CL wearers and are now presbyopic. This transition could be particularly important for patients who are presbyopic and astigmatic given that these two patients groups tend to struggle more with CLs than spherical CL wearers. Thus, the purpose of this work is to determine Total30 MFT overall comfort, vision, willingness to remain in CLs after the study, and satisfaction for those who currently wear reusable silicone hydrogel toric CLs and are now presbyopic. These data will provide valuable information to partitioners for patient educational purposes, and it will provide credence for refitting presbyopic patients who have astigmatism into Total30 MFT, especially after the onset of presbyopia.
- Conditions
- Contact Lenses, Presbyopia
- Being tested
- Total 30 multi foric contact lenses
- Keywords
- Optometry, Contact lens comfort
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total 30 multi foric contact lensesDevice
Participants will be refit into total 30 contact lenses
| Study group | Role | What they receive |
|---|---|---|
| TOTAL30 Multifocal Toric contact lenses | Experimental | This will be a prospective study to understand if reusable silicone hydrogel toric CL wearers who are presbyopic can be successfully refit into Total30 MFT CLs Receives: Device: Total 30 multi foric contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity scores
This will be a prospective study to understand if reusable silicone hydrogel toric CL wearers who are presbyopic can be successfully refit into Total30 MFT CLs VAS scores will be judged from -50 to positive 50 with positive numbers being more comfortable and 0 being neutral.
Measured: 1 month
Secondary outcomes (2)
Contact lens dry eye 8 questionnaire scores
Proportion of reusable silicone hydrogel toric CL wearers who have asymptomatic Contact Lens Dry Eye-8 (CLDEQ-8; scores <12) scores one month after wearing Total30 MFT CL
Measured: 1 month
Comfort VAS
Comfort VAS after application and at 8, 12, and 16 hours of wear on Day 1 (1st full day), Day14, and Day 29 via text.
Measured: Day 1, Day 14 and day 29 text messages
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study startApr 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact LensesStudies 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
- Previous reusable soft contact lens wearers will be refit into total 30 mft contact lenses;
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern College of Optometry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586982
- Sponsor's protocol ID
- IRB00006763-Total30MFT
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes