Clinical trial NCT06847230: How Does DT1 Sphere Perform in Current and Successful Acuvue MAX Wearers?
Official title: How Does DT1 Sphere Perform in Current and Successful Acuvue MAX Wearers?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Comfort and Successful Refitting
Keywords: Contact lenses
Contact lens comfort
Lead sponsor: Southern College of Optometry
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This 2-week, 3-visit clinical study will refit current Acuvue Max contact lens wearers into Dailies Total 1 contact lenses
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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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.

  6. 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.

  7. 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

Primary outcomes:
measure: Likelihood of continuing to wear DT1
timeFrame: 3 weeks
measure: Overall satisfaction while wearing DT1
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: The Southern College of Optometry
state: Tennessee
Study officials:
References: