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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03305484
Recruitment Status : Completed
First Posted : October 10, 2017
Last Update Posted : September 18, 2019
Sponsor:
Collaborators:
University of Houston
New England College of Optometry
Ohio State University
University of Waterloo
Pacific University
Nova Southeastern University
Alcon Research
Information provided by (Responsible Party):
Dawn Lam, MSc, OD, Southern California College of Optometry

Tracking Information
First Submitted Date October 4, 2017
First Posted Date October 10, 2017
Last Update Posted Date September 18, 2019
Actual Study Start Date December 30, 2017
Actual Primary Completion Date October 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 4, 2017)
  • Validation of the Contact Lens Risk Survey (CLRS) [ Time Frame: 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 [ Time Frame: 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Soft Contacts Observation of Risk and Education (SCORE)
Official Title Contact Lens Assessment in Youth - Soft Contacts Observation of Risk and Education (CLAY-SCORE)
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Contact Lens Complication
  • Contact Lens Acute Red Eye
  • Contact Lens Related Corneal Infiltrate (Disorder)
  • Contact Lens-Induced Corneal Fluorescein Staining
Intervention Other: No intervention
No intervention, observation only
Other Name: No intervention, observation only
Study Groups/Cohorts Symptomatic Contact Lens Wearers
Contact lens wearers who present to the eye care practitioner's office with a symptomatic red eye
Intervention: Other: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 17, 2019)
171
Original Estimated Enrollment
 (submitted: October 4, 2017)
232
Actual Study Completion Date April 16, 2019
Actual Primary Completion Date October 16, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03305484
Other Study ID Numbers SCCO-16-15
IIT#23485303 ( Other Grant/Funding Number: Alcon )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: No plans to share IPD
Responsible Party Dawn Lam, MSc, OD, Southern California College of Optometry
Study Sponsor Southern California College of Optometry
Collaborators
  • University of Houston
  • New England College of Optometry
  • Ohio State University
  • University of Waterloo
  • Pacific University
  • Nova Southeastern University
  • Alcon Research
Investigators
Principal Investigator: Dawn Lam Marshall B. Ketchum University
PRS Account Southern California College of Optometry
Verification Date September 2019