Ocular Characteristics in Contact Lens and Spectacle Wear
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03913377|
Recruitment Status : Completed
First Posted : April 12, 2019
Last Update Posted : June 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Visual Acuity||Device: Spectacles Device: ACUVUE OASYS®1-Day with HydraLuxe™ Technology||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ocular Characteristics in Contact Lens and Spectacle Wear|
|Actual Study Start Date :||April 9, 2019|
|Actual Primary Completion Date :||June 14, 2019|
|Actual Study Completion Date :||June 14, 2019|
Eligible subjects that are habitual spectacle wearers will use their habitual optical correction and undergo ocular evaluations and questionnaires at the baseline and 1-week visit.
Subjects' own habitual spectacles
Eligible subjects that are habitual contact lens wearers who own spectacles will be randomized into 1 of 2 sequences (Spectacle/ACUVUE OASYS 1-Day or ACUVUE OASYS 1-Day/Spectacle)
Subjects' own habitual spectacles
Device: ACUVUE OASYS®1-Day with HydraLuxe™ Technology
- Non-invasive break up time (NIBUT) [ Time Frame: up to 4-week follow-up ]Using a corneal topographer, NIBUT will be measured as the time interval in seconds after the final blink to the first appearance of distortion in the reflected rings; or to the time that the participant has to blink due to discomfort.
- Non-invasive keratography break up time (NIKBUT) [ Time Frame: up to 4-week follow-up ]Using a keratography instrument, NIKBUT will be measured as the time interval in seconds after the final blink to the first appearance of distortion in the reflected rings; or to the time that the participant has to blink due to discomfort.
- Meibomian Gland Expressibility [ Time Frame: up to 4-week follow-up ]Meibomian gland expressiblity is assessed in three regions of the lower eyelid: temporal, central, and nasal. Approximately five glands are expressed per region and evaluated using a four-grade scale: 0 = No Secretion, 1 = Inspissated, 2 = Colored/Cloudy Liquid, and 3 = Clear Liquid Oil. The total score is calculated as the sum of all grades across the three regions and ranges from 0 to 45.
- Conjunctival Staining [ Time Frame: up to 4-week follow-up ]Conjunctival staining is graded and recorded by quadrant (Superior, Inferior, Nasal, and Temporal) using the following grading scale: Grade 0 = None, Grade 1 = Trace, Grade 2 = Mild, Grade 3 = Moderate, and Grade 4 = Severe. Average grade can be calculated based on grades of the four quadrants.
- Lid Wiper Epitheliopathy [ Time Frame: up to 4-week follow-up ]Horizontal lid margin staining and sagittal lid margin staining are graded for each eyelid separately. The horizontal and sagittal grades are then averaged for each eyelid to obtain the upper lid average grade and lower lid average grade. The final grade is the average of the upper and lower lid average grades. Subjects can be classified according to their final grades for each eye. The classification is defined as follows: "None" for final grades of 0, "Mild" for final grades between 0.25 and 1.00, "Moderate" for final grades between 1.25 and 2.00, and "Severe" for final graded between 2.25 and 3.00.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913377
|United States, Florida|
|Jacksonville, Florida, United States, 32256|
|Sabal Eye Care|
|Longwood, Florida, United States, 32779|
|United States, New York|
|Manhattan Vision Associates|
|New York, New York, United States, 10022|