Contact Lens ComplicationSCORENCT03305484
Soft Contacts Observation of Risk and Education (SCORE)
An observational study of Contact Lens Complication and Contact Lens Acute Red Eye, run by Southern California College of Optometry at Marshall B. Ketchum University at 5 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Contact Lens Complication, Contact Lens Acute Red Eye, Contact Lens Related Corneal Infiltrate (Disorder)
- How many people
- 171 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 30 Dec 2017to 16 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
The Ohio State, College of Optometry
Columbus, Ohio, 43210
Nova Southeastern University College of Optometry
Fort Lauderdale, Florida, 33314
Marshall B. Ketchum University
Fullerton, California, 92831
University of Houston, College of Optometry
Houston, Texas, 77204
Canada1 site
University of Waterloo, Optometry and Vision Science
Waterloo, Ontario, N2L 3G1
About this study
Official title: Contact Lens Assessment in Youth - Soft Contacts Observation of Risk and Education (CLAY-SCORE)
Specific Aims
- Develop risk assessment scores for SCL wearers
- Test the scoring algorithm in SCL wearers who present with adverse events
- Explore targeted patient education to reduce risk behaviors associated with SCL wear.
Read the 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.
- Conditions
- Contact Lens Complication, Contact Lens Acute Red Eye, Contact Lens Related Corneal Infiltrate (Disorder), Contact Lens-Induced Corneal Fluorescein Staining
- Being tested
- No intervention
- Keywords
- contact lenses, red eye, corneal infiltrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Also called No intervention, observation only
No intervention, observation only
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic Contact Lens Wearers | Contact lens wearers who present to the eye care practitioner's office with a symptomatic red eye Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start30 Dec 2017
- Primary completion16 Oct 2018
- Study completion16 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Houston, New England College of Optometry, Ohio State University, University of Waterloo, Pacific University, Nova Southeastern University, Alcon Research
- Responsible party
- Principal investigator, Dawn Lam, MSc, OD, Southern California College of Optometry at Marshall B. Ketchum University
- Investigators
- Dawn Lam, Principal investigator, Marshall B. Ketchum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305484
- Sponsor's protocol ID
- SCCO-16-15
- Other IDs
- IIT#23485303
- Acronym
- SCORE
- Status last verified
- Sep 2019
- First submitted
- 4 Oct 2017
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contact Lens Assessment in Youth - Soft Contacts Observation of Risk and Education (CLAY-SCORE)
- ClinicalTrials.gov ID
- NCT03305484
- Acronym / sponsor ID
- SCORE / SCCO-16-15
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum UniversityUniversity, hospital or other
- Collaborators
- University of Houston, New England College of Optometry, Ohio State University, University of Waterloo, Pacific University, Nova Southeastern University, Alcon Research
- Study start
- 30 Dec 2017 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 16 Apr 2019 (actual)
- First posted
- 10 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Specific Aims
- Develop risk assessment scores for SCL wearers
- Test the scoring algorithm in SCL wearers who present with adverse events
- Explore targeted patient education to reduce risk behaviors associated with SCL wear.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic Contact Lens Wearers | – | Other: No interventionContact lens wearers who present to the eye care practitioner's office with a symptomatic red eye |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- CASES
Key exclusion criteria (8 listed)
- CASES
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionAlso: No intervention, observation onlyNo intervention, observation only | Other | Symptomatic Contact Lens Wearers |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Individual participant dataSharing planned: No. No plans to share IPD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Lam principal investigator
Marshall B. Ketchum University
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contact Lens Complication and Contact Lens Acute Red Eye, run by Southern California College of Optometry at Marshall B. Ketchum University at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the Contact Lens Risk Survey (CLRS) (time frame: twelve months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.