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OpenTrials
Completed

NCT Number: NCT06847230

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

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.

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Key information

Conditions

Contact Lens Comfort and Successful Refitting

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Southern College of Optometry

Memphis, Tennessee, 38104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Dailies total 1 contact lenses

Device

successful refit into dt1 will be determined

Primary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Southern College of Optometry

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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