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

NCT06847230 | Completed FDA Device

• 1 other identifier: 2024-07-01CL
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contact Lens Comfort and Successful Refitting

Keywords

Contact lenses; Contact lens comfort

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  3 weeks

Study Arms (1)

Dailies total 1 contact lenses

EXPERIMENTAL

Acuvue max wearers will be refit into dailies total 1

Device: Dailies total 1 contact lenses

Interventions

Dailies total 1 contact lenses DEVICE

successful refit into dt1 will be determined

Dailies total 1 contact lenses

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Southern College of Optometry: lead

Study Sites (1)

The Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This 2-week, 3-visit clinical study will refit current Acuvue Max contact lens wearers into Dailies Total 1 contact lenses

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: July 15, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 30, 2024
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

US (1)