Contact Lens Complication Clinical Trial
Official title:
Contact Lens Assessment in Youth - Soft Contacts Observation of Risk and Education (CLAY-SCORE)
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.
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.
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