Soft Contacts Observation of Risk and Education (SCORE) (SCORE)

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.

Study Overview

• Status: Completed
• Conditions: Contact Lens Complication; Contact Lens Acute Red Eye; Contact Lens Related Corneal Infiltrate (Disorder); Contact Lens-Induced Corneal Fluorescein Staining
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Actual): 171

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • University of Waterloo, Optometry and Vision Science
• United States
  • California
    • Fullerton, California, United States, 92831
      • Marshall B. Ketchum University
  • Florida
    • Fort Lauderdale, Florida, United States, 33314
      • Nova Southeastern University College of Optometry
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State, College of Optometry
  • Texas
    • Houston, Texas, United States, 77204
      • University of Houston, College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Symptomatic Contact Lens Wearers; Contact lens wearers who present to the eye care practitioner's office with a symptomatic red eye	Other: No intervention; No intervention, observation only; Other Names: No intervention, observation only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of the Contact Lens Risk Survey (CLRS)	This study will further validate the CORS and facilitate its translation into clinical practice. A scoring algorithm will be developed.	twelve months
Targeted Patient Education	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	twelve months

Collaborators and Investigators

• Sponsor: Southern California College of Optometry at Marshall B. Ketchum University
• Collaborators: Ohio State University; University of Houston; Alcon Research; University of Waterloo; Nova Southeastern University; Pacific University; New England College of Optometry
• Investigators: Principal Investigator: Dawn Lam, Marshall B. Ketchum University

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2017
• Primary Completion (Actual): October 16, 2018
• Study Completion (Actual): April 16, 2019

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (Actual): October 10, 2017

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: contact lenses; red eye; corneal infiltrate
• Other Study ID Numbers: SCCO-16-15; IIT#23485303 (Other Grant/Funding Number: Alcon)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No