Soft Contacts Observation of Risk and Education (SCORE)

NCT03305484 | Completed DMC

• 2 other identifiers: SCCO-16-15IIT#23485303
• Study Type: observational
• Target: 171
• Locations: 2 countries
• Sites: 5

Brief Summary

Specific Aims

1. 1.Develop risk assessment scores for SCL wearers
2. 2.Test the scoring algorithm in SCL wearers who present with adverse events
3. 3.Explore targeted patient education to reduce risk behaviors associated with SCL wear.

Conditions

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

Keywords

contact lenses; red eye; corneal infiltrate

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Symptomatic Contact Lens Wearers

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

Other: No intervention

Interventions

No intervention OTHER

No intervention, observation only

Also known as: No intervention, observation only

Symptomatic Contact Lens Wearers

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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
• 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
• years of age and gender and age-matched (± 3 years) to Case
• Have not had an eye care examination within the past three months

You may not qualify if:

• 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

Sponsors & Collaborators

• Southern California College of Optometry at Marshall B. Ketchum University: lead
• University of Houston: collaborator
• New England College of Optometry: collaborator
• Ohio State University: collaborator
• University of Waterloo: collaborator
• Pacific University: collaborator
• Nova Southeastern University: collaborator
• Alcon Research: collaborator

Study Sites (5)

Marshall B. Ketchum University

Fullerton, California, 92831, United States

Location

Nova Southeastern University College of Optometry

Fort Lauderdale, Florida, 33314, United States

Location

The Ohio State, College of Optometry

Columbus, Ohio, 43210, United States

Location

University of Houston, College of Optometry

Houston, Texas, 77204, United States

Location

University of Waterloo, Optometry and Vision Science

Waterloo, Ontario, N2L 3G1, Canada

Location

Study Officials

• Dawn Lam

  Marshall B. Ketchum University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 10, 2017
• Study Start: December 30, 2017
• Primary Completion: October 16, 2018
• Study Completion: April 16, 2019
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (4)