Soft Contacts Observation of Risk and Education (SCORE)

Contact Lens Complication Clinical Trial

— SCORE  

Official title:

Contact Lens Assessment in Youth - Soft Contacts Observation of Risk and Education (CLAY-SCORE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305484
• Other study ID #: SCCO-16-15
• Secondary ID: IIT#23485303
• Status: Completed
• Start date: December 30, 2017
• Est. completion date: April 16, 2019

Study information

• Verified date: September 2019
• Source: Southern California College of Optometry
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: April 16, 2019
• Est. primary completion date: October 16, 2018
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• No intervention
No intervention, observation only

Locations

Country	Name	City	State
Canada	University of Waterloo, Optometry and Vision Science	Waterloo	Ontario
United States	The Ohio State, College of Optometry	Columbus	Ohio
United States	Nova Southeastern University College of Optometry	Fort Lauderdale	Florida
United States	Marshall B. Ketchum University	Fullerton	California
United States	University of Houston, College of Optometry	Houston	Texas

Sponsors (8)

Lead Sponsor	Collaborator
Southern California College of Optometry	Alcon Research, New England College of Optometry, Nova Southeastern University, Ohio State University, Pacific University, University of Houston, University of Waterloo

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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