Soft Contacts Observation of Risk and Education (SCORE)

Completed

• Conditions: Contact Lens Complication; Contact Lens-Induced Corneal Fluorescein Staining; Contact Lens Related Corneal Infiltrate (Disorder); Contact Lens Acute Red Eye
• Interventions: Other: No intervention

• Registration Number: NCT03305484
• Lead Sponsor: Southern California College of Optometry at Marshall B. Ketchum University

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.

Study Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-04
• Study First Posted: 2017-10-10
• Study Start: 2017-12-30
• Primary Completion: 2018-10-16
• Study Completion: 2019-04-16
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Symptomatic Contact Lens Wearers	No intervention	Contact lens wearers who present to the eye care practitioner's office with a symptomatic red eye

Primary Outcome Measures

Name	Time	Method
Validation of the Contact Lens Risk Survey (CLRS)	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	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

Trial Locations

Locations (5)

Nova Southeastern University College of Optometry; 🇺🇸 Fort Lauderdale, Florida, United States

University of Houston, College of Optometry; 🇺🇸 Houston, Texas, United States

Marshall B. Ketchum University; 🇺🇸 Fullerton, California, United States

The Ohio State, College of Optometry; 🇺🇸 Columbus, Ohio, United States

University of Waterloo, Optometry and Vision Science; 🇨🇦 Waterloo, Ontario, Canada