CompletedNot Applicable

Treating Contact Lens Discomfort With Orthokeratology

United States46 participantsStarted 2018-08-07

Plain-language summary

The primary aim of this study is to understand if orthokeratology can be used to improve contact lens comfort and the secondary aim is understand patient adaptation to orthokeratology.

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: * A completed comprehensive eye exam within the past two years * Contact lens discomfort or discontinuation of contact lenses because of discomfort within the past 6 months * Able to wear the Emerald™ Contact Lens (Oprifocon A, Euclid Systems Corporation) * Refractive error better than -5.00 diopters with less than 1.50 diopters of cylinder * Keratometry values between 40.00 D and 46.00 D Exclusion Criteria: * Past orthokeratology use * Ocular surgery within the past 12 months * History of severe ocular trauma * Active ocular infection or inflammation * Ocular disease other than dry eye * Accutane or ocular medication use * Pregnant or breast feeding * A condition or situation that may put the subject at significant risk, confound the study results, or may significantly interfere with study participation

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

Contact Lens Comfort

Timeframe: 1 Month Compared to Baseline

Trial details

NCT IDNCT03566680

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-15

Results submitted2020-04-01

View on ClinicalTrials.gov More Dry Eye 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.