Soft Contacts Observation of Risk and Education (SCORE) (SCORE)
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|ClinicalTrials.gov Identifier: NCT03305484|
Recruitment Status : Completed
First Posted : October 10, 2017
Last Update Posted : September 18, 2019
- Develop risk assessment scores for SCL wearers
- Test the scoring algorithm in SCL wearers who present with adverse events
- Explore targeted patient education to reduce risk behaviors associated with SCL wear.
|Condition or disease||Intervention/treatment|
|Contact Lens Complication Contact Lens Acute Red Eye Contact Lens Related Corneal Infiltrate (Disorder) Contact Lens-Induced Corneal Fluorescein Staining||Other: No intervention|
This will be a multi-center, case-control prospective study. Subjects will be enrolled at five geographically diverse locations across North America. The intent is to enroll cases with new (untreated) red eyes and controls that are representative of the contact lens wearing population and test the new scoring algorithm on this population.
A total of 232 participants are expected to complete the study (116 case-control sets). Enrollment will be competitive. After consent, subjects will complete the Contact Lens Risk Survey (CLRS) online at www.claystudy.org. Data related to symptoms, medical history and anterior segment evaluation will be collected. Subjects will be treated as usual and customary by the investigator. No intervention of treatment in this study. Subjects will be asked to repeat the CLRS at one and six months post initial visit.
Initial factor analysis from the previous CLRS data were used to develop and test the CLRS algorithm. Five sub-scales were identified in the areas of contact lens care, contact lens dependence, hygiene, living arrangements and wellness. Assuming a 10% missing data rate, a total of 58 SCL wearers with "serious and significant" red eye events will allow for detection of 0.4 or larger effect size.
There are multiple steps to "compliant wear" of contact lenses and while many patients do many of the correct wear behaviors, it's not realistic for practitioners to re-educate all wearers on all of the steps necessary to successfully wear SCLs. The CLRS allows patients to quickly report their specific wear behaviors and then receive only the targeted information on which behaviors they are doing that puts them at higher risk. A previous CLAY study demonstrated good repeatability of the CLRS survey one week after initial fielding.
|Study Type :||Observational|
|Actual Enrollment :||171 participants|
|Official Title:||Contact Lens Assessment in Youth - Soft Contacts Observation of Risk and Education (CLAY-SCORE)|
|Actual Study Start Date :||December 30, 2017|
|Actual Primary Completion Date :||October 16, 2018|
|Actual Study Completion Date :||April 16, 2019|
Symptomatic Contact Lens Wearers
Contact lens wearers who present to the eye care practitioner's office with a symptomatic red eye
Other: No intervention
No intervention, observation only
Other Name: No intervention, observation only
- Validation of the Contact Lens Risk Survey (CLRS) [ Time Frame: twelve months ]This study will further validate the CORS and facilitate its translation into clinical practice. A scoring algorithm will be developed.
- Targeted Patient Education [ Time Frame: twelve months ]Scripted patient education will be generated based on the results of the Contact Lens Risk Survey (CLRS) to determine if changes in behavior at the one and six month time point
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305484
|United States, California|
|Marshall B. Ketchum University|
|Fullerton, California, United States, 92831|
|United States, Florida|
|Nova Southeastern University College of Optometry|
|Fort Lauderdale, Florida, United States, 33314|
|United States, Ohio|
|The Ohio State, College of Optometry|
|Columbus, Ohio, United States, 43210|
|United States, Texas|
|University of Houston, College of Optometry|
|Houston, Texas, United States, 77204|
|University of Waterloo, Optometry and Vision Science|
|Waterloo, Ontario, Canada, N2L 3G1|
|Principal Investigator:||Dawn Lam||Marshall B. Ketchum University|