Soft Contacts Observation of Risk and Education (SCORE)

Southern California College of Optometry at Marshall B. Ketchum University

Status: Completed

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

Treatments: Other: No intervention

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03305484

SCCO-16-15

IIT#23485303 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 171 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

171 participants in 1 patient group

Symptomatic Contact Lens Wearers

Description:

Contact lens wearers who present to the eye care practitioner's office with a symptomatic red eye

Treatment:

Other: No intervention