CompletedNot Applicable

Total30 Sphere Contact Lenses

United States48 participantsStarted 2022-01-03

Plain-language summary

The purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs.

Who can participate

Age range

18 Years – 45 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: * Current contact lens wearers who have 20/20 visual acuity or better * Minimally symptomatic as based upon Contact Lens Dry Eye Questionnaire scores (≤10) * Astigmatism better than or equal to 0.50 D in each eye * Must have regularly worn 2 week or monthly contact lenses within the past 6 months * Must provide a glasses prescription that is is less than 3 years old * Willing to start wearing their contact lenses between 6:00 AM and 8:00 AM and wear their contact lenses until 11:00 PM each day Exclusion Criteria: * Past or Current hard CL use * Any known systemic health conditions that are thought to alter tear film physiology * History of viral eye disease * History of ocular surgery * History of severe ocular trauma * Active ocular infection or inflammation * Currently using isotretinoin-derivatives * Currently using ocular medications * Currently using rewetting drops or artificial tear * Pregnant or breast feeding

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

Visual Analog Scale (VAS) Ocular Comfort

Timeframe: 1 month

Trial details

NCT IDNCT05183022

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-20

Results submitted2022-11-19

View on ClinicalTrials.gov More Contact Lens Complication trials

Who can participate

Age range

18 Years – 45 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.