CompletedNot Applicable

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

United States36 participantsStarted 2024-07-15

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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 degenerat…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Likelihood of continuing to wear DT1

Timeframe: 3 weeks

Overall satisfaction while wearing DT1

Timeframe: 3 weeks

Trial details

NCT IDNCT06847230

SponsorSouthern College of Optometry

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-01

View on ClinicalTrials.gov More Contact Lens Comfort and Successful Refitting trials