Clinical trial NCT03305484: Soft Contacts Observation of Risk and Education (SCORE)
Official title: Contact Lens Assessment in Youth - Soft Contacts Observation of Risk and Education (CLAY-SCORE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contact Lens Complication
Contact Lens Acute Red Eye
Contact Lens Related Corneal Infiltrate (Disorder)
Contact Lens-Induced Corneal Fluorescein Staining
Keywords: contact lenses
red eye
corneal infiltrate
Lead sponsor: Southern California College of Optometry at Marshall B. Ketchum University
Sponsor class: OTHER
Collaborators: name: University of Houston
name: New England College of Optometry
name: Ohio State University
name: University of Waterloo
name: Pacific University
name: Nova Southeastern University
name: Alcon Research
First posted: 2017-10-10
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 232 participants are expected to complete the study (116 case-control sets). Enrollment will be competitive; with each of five geographic locations in the United States and Canada enrolling approximately 24, but no more than 29 case-control sets until the total sample size of is achieved.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Validation of the Contact Lens Risk Survey (CLRS)
timeFrame: twelve months
measure: Targeted Patient Education
timeFrame: twelve months
Secondary outcomes:
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Marshall B. Ketchum University
state: California
city: Fort Lauderdale
country: United States
facility: Nova Southeastern University College of Optometry
state: Florida
city: Columbus
country: United States
facility: The Ohio State, College of Optometry
state: Ohio
city: Houston
country: United States
facility: University of Houston, College of Optometry
state: Texas
city: Waterloo
country: Canada
facility: University of Waterloo, Optometry and Vision Science
state: Ontario
Study officials:
affiliation: Marshall B. Ketchum University
name: Dawn Lam
role: PRINCIPAL_INVESTIGATOR
References: