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

Southern College of Optometry

Status

Completed

Conditions

Contact Lens Comfort and Successful Refitting

Treatments

Device: Dailies total 1 contact lenses

Study type

Interventional

Funder types

Other

Identifiers

NCT06847230

2024-07-01CL

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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