Status:
COMPLETED
Soft Contacts Observation of Risk and Education (SCORE)
Lead Sponsor:
Southern California College of Optometry at Marshall B. Ketchum University
Collaborating Sponsors:
University of Houston
New England College of Optometry
Conditions:
Contact Lens Complication
Contact Lens Acute Red Eye
Eligibility:
All Genders
18-39 years
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 behav...
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 30 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 16 2019
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT03305484
Start Date
December 30 2017
End Date
April 16 2019
Last Update
September 18 2019
Active Locations (5)
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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