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.

Study Overview

• Status: Completed
• Conditions: Contact Lens Comfort and Successful Refitting
• Intervention / Treatment: Device: Dailies total 1 contact lenses

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dailies total 1 contact lenses; Acuvue max wearers will be refit into dailies total 1	Device: Dailies total 1 contact lenses; successful refit into dt1 will be determined

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Southern College of Optometry

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): February 26, 2025

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Contact lenses; Contact lens comfort
• Other Study ID Numbers: 2024-07-01CL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes