Contact Lens Comfort and Successful Refitting
Conditions
Keywords
Contact lenses, Contact lens comfort
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.
Interventions
DEVICEDailies total 1 contact lenses
successful refit into dt1 will be determined
Sponsors
Southern College of Optometry
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This 2-week, 3-visit clinical study will refit current Acuvue Max contact lens wearers into Dailies Total 1 contact lenses
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Likelihood of continuing to wear DT1 | 3 weeks | A Likert questionnaire will be used to determine patient-reported outcomes -50 being uncomfortable and 50 being extremely comfortbale |
| Overall satisfaction while wearing DT1 | 3 weeks | 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. |
Countries
United States
Outcome results
None listed