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CompletedNCT06847230Updated Aug 12, 2025

How Does DT1 Sphere Perform in Current and Successful Acuvue MAX Wearers?

An interventional study of Dailies total 1 contact lenses in Contact Lens Comfort and Successful Refitting, sponsored by Southern College of Optometry. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-12.

Sponsored by Southern College of Optometry · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2024, 1 year 11 months ago, and no results have been posted to the registry.
  • Registered 7 months after the study started (first participant enrolled Jul 2024, registered Feb 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Contact Lens Comfort and Successful Refitting

Keywords

  • Contact lenses
  • Contact lens comfort
03

In context

Lead sponsor

Southern College of Optometry is the lead sponsor of 15 studies on the registry; 9 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Dailies total 1 contact lenses

    Acuvue max wearers will be refit into dailies total 1

    Device: Dailies total 1 contact lenses

Interventions

  • DeviceDailies total 1 contact lenses

    successful refit into dt1 will be determined

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 weeks

  2. 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.

    Time frame: 3 weeks

07

Study locations

1 site
  • The Southern College of Optometry
    Memphis, Tennessee 38104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06847230
Lead sponsor
Southern College of Optometry
Responsible party
Sponsor
First posted
Feb 26, 2025
Start date
Jul 15, 2024
Primary completion
Nov 1, 2024
Completion
Nov 30, 2024
Last update
Aug 12, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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