MyopiaNCT07284966
Comfort and Vision With TOTAL30 Multifocal Lenses
An observational study of Myopia and Presbyopia, run by Scripps Poway Eyecare and Optometry at 1 site in United States.
Trial summary
This study is a single-arm, prospective, observational study conducted at one site to evaluate the comfort and vision of the TOTAL30 Multifocal (T30MF) contact lenses over the course of long wear days. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Myopia, Presbyopia, Astigmatism
- What is being tested?
- TOTAL30 Multifocal
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2026to 4 Aug 2026
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 40 years or older who currently wear soft multi-focal contact lenses.
Who may be able to join
- Subjects are eligible for the study if they meet the following criteria:
- Subjects who currently wear soft multi-focal contact lenses and score <12 on an entering CLDEQ-8 survey.
- Subjects who are >= 40 years old.
- Subjects who can and are willing to wear their lenses for 13 hours per day during the study period, and 16 hours per day when questionnaires are being taken.
- Willing to insert their contact lenses between 6:00 am and 8:00 am on the days when questionnaires will be taken.
- Vision correctable in soft multi-focal contact lenses to 20/25 (0.10 log MAR) or better in each eye at 6M.
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- Must be able to be successfully fit into the prescription parameters available for Total30 MF contact lenses.
- Required to have a smartphone and receive push notifications.
- Willing to attend all study visits.
- Willing to be diligent about answering the timed surveys in a prompt manner.
Who cannot join
- If any of the following exclusion criteria are applicable, the subject should not be enrolled in the study.
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
- Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator.
- Use of isotretinoin-derivatives.
- Use of lubricating drops.
- Monocular patients or patients fit with only 1 multifocal lens.
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- Prior refractive surgery.
- History of herpetic keratitis, ocular surgery, or irregular cornea.
- Pregnant or lactating.
- Having participated in a clinical trial in the past 30 days.
- High-ADD habitual wearers using a different fitting approach than Alcon's multifocal fitting guide (e.g., J\&J or CooperVision's fitting guide adopting a modified monovision approach).
- Are past rigid CL wearers.
- Have a history of being diagnosed with dry eye or ocular allergies.
- Have history of severe ocular trauma.
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Optometric Group
San Diego, California, 92131
About this study
Official title: Evaluation of Wear Comfort and Vision With Total 30 Multifocal Lenses Over 16 Hours of Wear
This study is a single-arm, prospective, observational study conducted at one site to evaluate the comfort and vision of the TOTAL30 Multifocal (T30MF) contact lenses over the course of long wear days. The study will assess the proportion of positive subjective Visual Analog Scale (VAS) assessments of comfort and vision at 10, 12, 14, and 16 hours of wear on Days 1, 7, 14, and 30. Additionally, the study will explore subjective assessments of lens comfort using the CLDEQ-8 survey and measure logMAR visual acuity at both distance and near at Visit 1, Visit 2, and after 1 month of lens wear. Participants will undergo three site visits, with at-home surveys conducted at specified intervals to gather real-time data on comfort and vision.
- Conditions
- Myopia, Presbyopia, Astigmatism
- Being tested
- TOTAL30 Multifocal
- Medical subject headings
- Myopia, Presbyopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOTAL30 MultifocalDevice
TOTAL30 Multifocal
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported comfort level of the TOTAL30 Multifocal Lens
Comfort level assessed using real-time patient-reported data collected at multiple time points throughout the day, with a focus on the end of the wear period. Patients are asked "What is your impression of the COMFORT of these study lenses?" and provide and answer from -50 (Extremely uncomfortable) to +50 (Extremely comfortable) using a sliding digital scale.
Measured: 16 hours of wear on specified days over a 30-day period
Secondary outcomes (1)
Patient-reported vision quality with the TOTAL30 Multifocal Lens
Vision quality assessed using real-time patient-reported data collected at various time points during the day. Patients are asked "What is your impression of the VISION quality of these study lenses?" and provide and answer from -50 (Poor quality) to +50 (Excellent quality) using a sliding digital scale.
Measured: 16 hours of wear on specified days over a 30-day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start5 Feb 2026
- Primary completion4 Aug 2026
- Study completion4 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Poway Eyecare and Optometry
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Jay Mashouf, OD, Principal investigator, Scripps Optometric Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284966
- Sponsor's protocol ID
- JM-25-02
- Status last verified
- Sep 2026
- First submitted
- 21 Nov 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Wear Comfort and Vision With Total 30 Multifocal Lenses Over 16 Hours of Wear
- ClinicalTrials.gov ID
- NCT07284966
- Acronym / sponsor ID
- JM-25-02
- Conditions
- Myopia, Presbyopia, Astigmatism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Scripps Poway Eyecare and OptometryUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 4 Aug 2026 (actual)
- Study completion
- 4 Aug 2026 (actual)
- First posted
- 16 Dec 2025 (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 is a single-arm, prospective, observational study conducted at one site to evaluate the comfort and vision of the TOTAL30 Multifocal (T30MF) contact lenses over the course of long wear days. The study will assess the proportion of positive subjective Visual Analog Scale (VAS) assessments of comfort and vision at 10, 12, 14, and 16 hours of wear on Days 1, 7, 14, and 30. Additionally, the study will explore subjective assessments of lens comfort using the CLDEQ-8 survey and measure logMAR visual acuity at both distance and near at Visit 1, Visit 2, and after 1 month of lens wear. Participants will undergo three site visits, with at-home surveys conducted at specified intervals to gather real-time data on comfort and vision.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 40 years or older who currently wear soft multi-focal contact lenses.
Key inclusion criteria (10 listed)
- Subjects who currently wear soft multi-focal contact lenses and score <12 on an entering CLDEQ-8 survey.
- Subjects who are >= 40 years old.
- Subjects who can and are willing to wear their lenses for 13 hours per day during the study period, and 16 hours per day when questionnaires are being taken.
- Willing to insert their contact lenses between 6:00 am and 8:00 am on the days when questionnaires will be taken.
- Vision correctable in soft multi-focal contact lenses to 20/25 (0.10 log MAR) or better in each eye at 6M.
Key exclusion criteria (14 listed)
- If any of the following exclusion criteria are applicable, the subject should not be enrolled in the study.
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
- Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator.
- Use of isotretinoin-derivatives.
- Use of lubricating drops.
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 MultifocalTOTAL30 Multifocal | Device | – |
Primary outcome
Patient-reported comfort level of the TOTAL30 Multifocal Lens
Time frame: 16 hours of wear on specified days over a 30-day period
Comfort level assessed using real-time patient-reported data collected at multiple time points throughout the day, with a focus on the end of the wear period. Patients are asked "What is your impression of the COMFORT of these study lenses?" and provide and answer from -50 (Extremely uncomfortable) to +50 (Extremely comfortable) using a sliding digital scale.
1 secondary outcome
Patient-reported vision quality with the TOTAL30 Multifocal Lens
Time frame: 16 hours of wear on specified days over a 30-day period
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 4 Sep 2026.
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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.
Jay Mashouf, OD principal investigator
Scripps Optometric Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and Presbyopia, run by Scripps Poway Eyecare and Optometry 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 10 inclusion and 14 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 4 Sep 2026. 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?
Patient-reported comfort level of the TOTAL30 Multifocal Lens (time frame: 16 hours of wear on specified days over a 30-day period). 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 4 Sep 2026.