NCT03305484

Soft Contacts Observation of Risk and Education (SCORE)

Contact Lens Assessment in Youth - Soft Contacts Observation of Risk and Education (CLAY-SCORE)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 171 (actual)
• Sponsor: Southern California College of Optometry at Marshall B. Ketchum University · Academic / Other
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: —

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.

Detailed description

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.

Conditions

• Contact Lens Complication
• Contact Lens Acute Red Eye
• Contact Lens Related Corneal Infiltrate (Disorder)
• Contact Lens-Induced Corneal Fluorescein Staining

Interventions

Type	Name	Description
OTHER	No intervention	No intervention, observation only

Timeline

• Start date: 2017-12-30
• Primary completion: 2018-10-16
• Completion: 2019-04-16
• First posted: 2017-10-10
• Last updated: 2019-09-18

Locations

5 sites across 2 countries: United States, Canada