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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05027087 -
The Effect of a Novel Blueberry Supplement on Dry Eye Disease
|
Phase 3 | |
Completed |
NCT05102409 -
An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease
|
Phase 2 | |
Completed |
NCT06159569 -
Performance and Tolerability of the Medical Device LACRIACT
|
N/A | |
Completed |
NCT04081610 -
Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution
|
Phase 1 | |
Completed |
NCT05062564 -
Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye
|
N/A | |
Completed |
NCT05825599 -
PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms
|
N/A | |
Completed |
NCT03418727 -
Dry Eye Disease Study With Brimonidine
|
Phase 2 | |
Active, not recruiting |
NCT04425551 -
Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction
|
N/A | |
Recruiting |
NCT04527887 -
Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED)
|
Phase 4 | |
Not yet recruiting |
NCT06379685 -
Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface.
|
Phase 1 | |
Active, not recruiting |
NCT05618730 -
Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B
|
Phase 1 | |
Completed |
NCT04553432 -
Dry Eye OmniLenz Application of Omnigen Research Study
|
Phase 4 | |
Recruiting |
NCT04109170 -
Dry Eye Evaluation System Based on Bioinformatics
|
||
Completed |
NCT04105842 -
Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type
|
N/A | |
Completed |
NCT05505292 -
Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers
|
Phase 4 | |
Completed |
NCT04668131 -
Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease
|
N/A | |
Completed |
NCT06176651 -
Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers
|
Phase 4 | |
Not yet recruiting |
NCT02218827 -
Topical Steroid Treatment For Dry Eye
|
N/A | |
Completed |
NCT02235259 -
Efficacy and Safety of XG-104 for the Treatment of Dry Eye
|
Phase 2 | |
Completed |
NCT01959854 -
Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye
|
N/A |