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

Not Applicable

Completed

• Conditions: Contact Lens Comfort and Successful Refitting

• Registration Number: NCT06847230
• Lead Sponsor: Southern College of Optometry

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-15
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-30
• Status Verified: 2025-02
• Study First Submitted: 2025-02-21
• Study First Submitted QC: 2025-02-21
• Last Update Submitted: 2025-02-21
• Study First Posted: 2025-02-26
• Last Update Posted: 2025-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Adults, 18- to 40-year-old, Oasys MAX 1-day CL wearers with best-corrected 20/20 visual acuity or better.

2. 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.

3. 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).

4. Participants will be required to be able to wear DT1 Sphere CLs (astigmatism < 0.75D OD/OS).

5. Participants will be required to wear the study CLs for ≥12 hours with no overnight wear

6. Participants will be required to use digital devices at least 8 hours/day.

7. Participants will be required to provide a glasses prescription that is less than 3 years old.

Exclusion Criteria

• 1. Have presbyopia and/or need a reading add as determined during their initial manifest refraction.

  2. Have worn DT1 in the past for more than 1 week. 3. Are past rigid CL wearers. 4. Have a history of being diagnosed with dry eye or ocular allergies. 5. Have known systemic health conditions that are thought to alter tear film physiology.

  3. 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.

  4. Have a history of viral eye disease. 8. Have a history of ocular surgery. 9. Have a history of severe ocular trauma. 10. Have a history of corneal dystrophies or degenerations. 11. Have active ocular infection or inflammation. 12. Are currently using isotretinoin-derivatives or ocular medications. 13. Are pregnant or breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Likelihood of continuing to wear DT1	3 weeks	A Likert questionnaire will be used to determine patient-reported outcomes
Overall satisfaction while wearing DT1	3 weeks	A Likert questionnaire will be used to determine patient-reported outcomes

Trial Locations

Locations (1)

The Southern College of Optometry; 🇺🇸 Memphis, Tennessee, United States