Soft Contacts Observation of Risk and Education (SCORE)

• Sponsor: Southern California College of Optometry at Marshall B. Ketchum University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03305484
• Collaborator: University of Houston (Other), New England College of Optometry (Other), Ohio State University (Other), University of Waterloo (Other), Pacific University (Other), Nova Southeastern University (Other), Alcon Research (Industry)
• Enrollment: 171
• Locations: 5
• Actual Duration (Months): 15.5
• Patients Per Site: 34.2
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational
• Actual Enrollment: 171 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Contact Lens Assessment in Youth - Soft Contacts Observation of Risk and Education (CLAY-SCORE)
• Actual Study Start Date: Dec 30, 2017
• Actual Primary Completion Date: Oct 16, 2018
• Actual Study Completion Date: Apr 16, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Validation of the Contact Lens Risk Survey (CLRS) [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marshall B. Ketchum University	Fullerton	California	United States	92831
2	Nova Southeastern University College of Optometry	Fort Lauderdale	Florida	United States	33314
3	The Ohio State, College of Optometry	Columbus	Ohio	United States	43210
4	University of Houston, College of Optometry	Houston	Texas	United States	77204
5	University of Waterloo, Optometry and Vision Science	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• Southern California College of Optometry at Marshall B. Ketchum University
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dawn Lam, MSc, OD, Associate Professor, Southern California College of Optometry at Marshall B. Ketchum University
• ClinicalTrials.gov Identifier: NCT03305484
• Other Study ID Numbers: SCCO-16-15; IIT#23485303
• First Posted: Oct 10, 2017
• Last Update Posted: Sep 18, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Associate Professor, Southern California College of Optometry at Marshall B. Ketchum University: contact lenses; red eye; corneal infiltrate

Study Results

No Results Posted as of Sep 18, 2019