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

NCT ID: NCT06847230

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2024-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dailies total 1 contact lenses

Acuvue max wearers will be refit into dailies total 1

Group Type: EXPERIMENTAL

Dailies total 1 contact lenses

Intervention Type: DEVICE

successful refit into dt1 will be determined

Interventions

Dailies total 1 contact lenses

successful refit into dt1 will be determined

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Southern College of Optometry

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Southern College of Optometry

Memphis, Tennessee, United States

Countries

United States

Other Identifiers

2024-07-01CL

Identifier Type: -

Identifier Source: org_study_id