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

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ClinicalTrials.gov Identifier: NCT03305484
Recruitment Status : Not yet recruiting
First Posted : October 10, 2017
Last Update Posted : October 10, 2017
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

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.

Condition or disease Intervention/treatment
Contact Lens Complication Contact Lens Acute Red Eye Contact Lens Related Corneal Infiltrate (Disorder) Contact Lens-Induced Corneal Fluorescein Staining 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.


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Study Type : Observational
Estimated Enrollment : 232 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Contact Lens Assessment in Youth - Soft Contacts Observation of Risk and Education (CLAY-SCORE)
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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 Name: No intervention, observation only




Primary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes 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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305484


Contacts
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Contact: Dawn Lam, OD 7145018879 dlam@ketchum.edu
Contact: Jerry Paugh, OD 7144497487 jpaugh@ketchum.edu

Locations
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United States, California
Marshall B. Ketchum University Not yet recruiting
Fullerton, California, United States, 92831
Contact: Dawn Lam, OD    714-501-8879    dlam@ketchum.edu   
Contact: Jerry Paugh, OD    7144497487    jpaugh@ketchum.edu   
Sub-Investigator: Justin Kwan, OD         
Sub-Investigator: Edeline Lu, OD         
Sub-Investigator: Elaine Chen, OD         
United States, Florida
Nova Southeastern University College of Optometry Not yet recruiting
Fort Lauderdale, Florida, United States, 33314
Contact: Chandra Mickles, OD    908-675-1543    cmickles@nova.edu   
Principal Investigator: Chandra Mickles, OD         
United States, Ohio
The Ohio State, College of Optometry Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Heidi Wagner, OD    614-292-4196    wagner.10@osu.edu   
Contact: Aaron Zimmerman, OD    614-247-6188    zimmerman.178@osu.edu   
Principal Investigator: Aaron Zimmerman, OD         
United States, Texas
University of Houston, College of Optometry Not yet recruiting
Houston, Texas, United States, 77204
Contact: Kathryn Richdale, OD       richdale@central.uh.edu   
Contact: Eric Ritchey, OD    614-596-7477    erritche@central.uh.edu   
Principal Investigator: Kathryn Richdale, OD         
Principal Investigator: Eric Ritchey, OD         
Sub-Investigator: Ashley Tucker, OD         
Canada, Ontario
University of Waterloo, Optometry and Vision Science Not yet recruiting
Waterloo, Ontario, Canada, N2L 3G1
Contact: Luigina Sorbara, OD    905-702-2451    gsorbara@uwaterloo.ca   
Principal Investigator: Luigina Sorbara, OD         
Sponsors and Collaborators
Southern California College of Optometry
University of Houston
New England College of Optometry
Ohio State University
University of Waterloo
Pacific University
Nova Southeastern University
Alcon Research
Investigators
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Principal Investigator: Dawn Lam Marshall B. Ketchum University

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Responsible Party: Dawn Lam, MSc, OD, Associate Professor, Southern California College of Optometry
ClinicalTrials.gov Identifier: NCT03305484     History of Changes
Other Study ID Numbers: SCCO-16-15
IIT#23485303 ( Other Grant/Funding Number: Alcon )
First Posted: October 10, 2017    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dawn Lam, MSc, OD, Southern California College of Optometry:
contact lenses
red eye
corneal infiltrate