CompletedNot Applicable

Soft Contacts Observation of Risk and Education (SCORE)

United States, Canada171 participantsStarted 2017-12-30

Plain-language summary

Specific Aims 1. Develop risk assessment scores for SCL wearers 2. Test the scoring algorithm in SCL wearers who present with adverse events 3. Explore targeted patient education to reduce risk behaviors associated with SCL wear.

Who can participate

Age range

18 Years – 39 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: * CASES * Current SCL wear (as defined by having worn lenses in previous week) without restriction on lens material, design, indication, wearing schedule or lens power * 18 - 39 years of age * New (untreated) symptomatic red eye CONTROLS * Current SCL wear (as defined by having worn lenses in previous week) without restriction on lens material, design, indication, wearing schedule or lens power * 18 - 39 years of age and gender and age-matched (± 3 years) to Case * Have not had an eye care examination within the past three months Exclusion Criteria: * CASES * Faculty, staff or student at an optometry college or school * Family or household member of an eye care provider, ophthalmic technician, ophthalmology or optometry residents or optometry students * Pregnancy (by self-report) * Currently enrolled in another eye/vision clinical trial * Previous participant in a CLAY study * Wearing SCL in conjunction with gas permeable (GP) lenses (i.e., piggyback design, hybrid lens.) CONTROLS * Same exclusion criteria as cases

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

Validation of the Contact Lens Risk Survey (CLRS)

Timeframe: twelve months

Targeted Patient Education

Timeframe: twelve months

Trial details

NCT IDNCT03305484

SponsorSouthern California College of Optometry at Marshall B. Ketchum University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-10-16

View on ClinicalTrials.gov More Contact Lens Complication trials

Who can participate

Age range

18 Years – 39 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.