Dry Eye Clinical Trial
Official title:
Treating Contact Lens Discomfort With Orthokeratology
Verified date | August 2020 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary aim of this study is to understand if orthokeratology can be used to improve contact lens comfort and the secondary aim is understand patient adaptation to orthokeratology.
Status | Completed |
Enrollment | 46 |
Est. completion date | June 15, 2019 |
Est. primary completion date | April 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - A completed comprehensive eye exam within the past two years - Contact lens discomfort or discontinuation of contact lenses because of discomfort within the past 6 months - Able to wear the Emerald™ Contact Lens (Oprifocon A, Euclid Systems Corporation) - Refractive error better than -5.00 diopters with less than 1.50 diopters of cylinder - Keratometry values between 40.00 D and 46.00 D Exclusion Criteria: - Past orthokeratology use - Ocular surgery within the past 12 months - History of severe ocular trauma - Active ocular infection or inflammation - Ocular disease other than dry eye - Accutane or ocular medication use - Pregnant or breast feeding - A condition or situation that may put the subject at significant risk, confound the study results, or may significantly interfere with study participation |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Contact Lens Comfort | Contact lens comfort was measured with the Contact Lens Dry Eye Questionnaire-8 (Range = 0 to 28 with lower scores being better). Subjects were required to have Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) scores of 12 or greater in order to participate in this study. | 1 Month Compared to Baseline | |
Secondary | Contact Lens Comfort | Contact lens comfort was measured with the Contact Lens Dry Eye Questionnaire-4 (Range = 0 to 18 with lower scores being better). | 1 Week Compared to Baseline | |
Secondary | Contact Lens Comfort | Eye comfort will be measured with the Contact Lens Dry Eye Questionnaire-4 (Range = 0 to 18 with lower scores being better). | 3 Month Compared to Baseline | |
Secondary | Non-Invasive Tear Break-Up Time | This is a measure of tear stability (Measured in seconds with higher amounts of time being better). | 1 Month Compared to Baseline | |
Secondary | Tear Meniscus Height | This is a measure of tear volume (Measured in millimeters with higher heights being better). | 1 Month Compared to Baseline | |
Secondary | Phenol Red Thread | This is a measure of tear volume (Range = 0 to 75 millimeters with higher values being better). | 1 Month Compared to Baseline |
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