Contact Lens Comfort and Successful RefittingNCT06847230
How Does DT1 Sphere Perform in Current and Successful Acuvue MAX Wearers?
A study testing Dailies total 1 contact lenses in people with Contact Lens Comfort and Successful Refitting, run by Southern College of Optometry at 1 site in United States.
Trial summary
The goal of this prospective study is to to understand if satisfied MAX Contact lens (CL)wearers can be successfully refit into Dailies total 1 (DT1) CL in healthy MAX CL wearers between the ages of 18-40. 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 Comfort and Successful Refitting
- What is being tested?
- Dailies total 1 contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2024to 30 Nov 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
- Adults, 18- to 40-year-old, Oasys MAX 1-day CL wearers with best-corrected 20/20 visual acuity or better.
- Participants will be required to have worn Oasys MAX 1-day CLs for at least 3 months in the past year and currently wearing these CLs.
- All participants will be required to have a CLDEQ-8 score <12 while wearing their habitual CLs (Oasys MAX 1-days) and to indicate that they are satisfied with Oasys MAX 1-day CLs (Yes/No).
- Participants will be required to be able to wear DT1 Sphere CLs (astigmatism < 0.75D OD/OS).
- Participants will be required to wear the study CLs for ≥12 hours with no overnight wear
- Participants will be required to use digital devices at least 8 hours/day.
- Participants will be required to provide a glasses prescription that is less than 3 years old.
Who cannot join
- Have presbyopia and/or need a reading add as determined during their initial manifest refraction.
- Have worn DT1 in the past for more than 1 week.
- Are past rigid CL wearers.
- 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 corrected acuity 1 line or more worse vision recorded at Visit 2 (compared to the Visit 1 findings) with their optimized Oasys MAX 1-day lenses.
Show all 13Show fewer
- Have a history of viral eye disease.
- 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.
United States1 site
The Southern College of Optometry
Memphis, Tennessee, 38104
About this study
The goal of this prospective study is to to understand if satisfied MAX Contact lens (CL)wearers can be successfully refit into Dailies total 1 (DT1) CL in healthy MAX CL wearers between the ages of 18-40. The main question is to determine the number of participants who can successfully be re-fit into DT1 CL, by utilizing a cldeq-8 questionnaire as well as an investigator developed questionnaire to gauge comfort and satisfaction.
- Being tested
- Dailies total 1 contact lenses
- Keywords
- Contact lenses, Contact lens comfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dailies total 1 contact lensesDevice
successful refit into dt1 will be determined
| Study group | Role | What they receive |
|---|---|---|
| Dailies total 1 contact lenses | Experimental | Acuvue max wearers will be refit into dailies total 1 Receives: Device: Dailies total 1 contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likelihood of continuing to wear DT1
A Likert questionnaire will be used to determine patient-reported outcomes -50 being uncomfortable and 50 being extremely comfortbale
Measured: 3 weeks
Overall satisfaction while wearing DT1
A Likert questionnaire will be used to determine patient-reported outcomes. With answers that are positive such as strongly agree to product satisfaction are better.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start15 Jul 2024
- Primary completion1 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens Comfort and Successful RefittingStudies 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 2-week, 3-visit clinical study will refit current Acuvue Max contact lens wearers into Dailies Total 1 contact lenses
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
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
- NCT06847230
- Sponsor's protocol ID
- 2024-07-01CL
- Status last verified
- Aug 2025
- First submitted
- 21 Feb 2025
- Last updated
- 12 Aug 2025
- 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does DT1 Sphere Perform in Current and Successful Acuvue MAX Wearers?
- ClinicalTrials.gov ID
- NCT06847230
- Acronym / sponsor ID
- 2024-07-01CL
- Keywords
- Contact lenses, Contact lens comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Southern College of OptometryUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 26 Feb 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.
The goal of this prospective study is to to understand if satisfied MAX Contact lens (CL)wearers can be successfully refit into Dailies total 1 (DT1) CL in healthy MAX CL wearers between the ages of 18-40. The main question is to determine the number of participants who can successfully be re-fit into DT1 CL, by utilizing a cldeq-8 questionnaire as well as an investigator developed questionnaire to gauge comfort and satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This 2-week, 3-visit clinical study will refit current Acuvue Max contact lens wearers into Dailies Total 1 contact lenses
| Arm | Type | Receives |
|---|---|---|
| Dailies total 1 contact lenses | Experimental | Device: Dailies total 1 contact lensesAcuvue max wearers will be refit into dailies total 1 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adults, 18- to 40-year-old, Oasys MAX 1-day CL wearers with best-corrected 20/20 visual acuity or better.
- Participants will be required to have worn Oasys MAX 1-day CLs for at least 3 months in the past year and currently wearing these CLs.
- All participants will be required to have a CLDEQ-8 score <12 while wearing their habitual CLs (Oasys MAX 1-days) and to indicate that they are satisfied with Oasys MAX 1-day CLs (Yes/No).
- Participants will be required to be able to wear DT1 Sphere CLs (astigmatism < 0.75D OD/OS).
- Participants will be required to wear the study CLs for ≥12 hours with no overnight wear
Key exclusion criteria (13 listed)
- Have presbyopia and/or need a reading add as determined during their initial manifest refraction.
- Have worn DT1 in the past for more than 1 week.
- Are past rigid CL wearers.
- 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.
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 |
|---|---|---|
| Dailies total 1 contact lensessuccessful refit into dt1 will be determined | Device | Dailies total 1 contact lenses |
Primary outcome
Likelihood of continuing to wear DT1
Time frame: 3 weeks
A Likert questionnaire will be used to determine patient-reported outcomes -50 being uncomfortable and 50 being extremely comfortbale
Overall satisfaction while wearing DT1
Time frame: 3 weeks
A Likert questionnaire will be used to determine patient-reported outcomes. With answers that are positive such as strongly agree to product satisfaction are better.
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 12 Aug 2025.
Related trials for Contact Lens Comfort and Successful Refitting
Recruiting
Refitting Satisfied INFUSE One-Day Multifocal Wearers to DAILIES TOTAL1 Multifocal Contact Lenses
Contact Lens Comfort and Successful Refitting, Presbyopia
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 Dailies total 1 contact lenses in people with Contact Lens Comfort and Successful Refitting, run by Southern College of 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 7 inclusion and 13 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 12 Aug 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?
Likelihood of continuing to wear DT1 (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 12 Aug 2025.