Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a two-arm, open-label, bilateral dispensing clinical investigation. Eligible subjects will proceed to either a low-sphere or high-sphere arm based on refraction measurements in the baseline assessment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Sphere | Other | Subjects with a spherical refraction between -1.75 DS and -6.00 DS |
|
| Low Sphere | Other | Subjects with a spherical refraction between -1.50 DS and +1.00 DS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JJVC Marketed Contact Lens | Device | Acuvue Oasys® 1-Day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scales (VAS) | Subjective comfort and visual fatigue will be assessed using 0 to 100 on VAS at the start of the visit and at the end of each visual task. | at approximately 2-week follow-up |
| Tear film surface quality | Tear film surface quality will be assessed in the left eye (OS) only. The infrared-reflected mires from the tear film will be analyzed using custom image analysis from video recordings. The mean and standard deviation of tear film surface quality metric will be determined across the 5 minutes and at 1-minute increments. | at approximately 2-week follow-up |
| Tear meniscus height | The lower tear meniscus in the left eye (OS) only will be analyzed using custom image analysis from video recordings. The mean and SD of tear meniscus height (measured vertically in millimeters) will be determined across the 5 minutes and at 1-minute increments. | at approximately 2-week follow-up |
| Blink frequency | Blink frequency will be analyzed using custom image analysis from video recordings. Three blink rate metrics will be determined:
Each blink frequency metric will be determined across the 5 minutes and at 1-minute increments. | at approximately 2-week follow-up |
| Interblink interval | The distribution of interblink intervals (seconds) over the 5-minute measurement period and at 1-minute increments will be determined in two ways:
The number of times the interblink interval exceeds the mean + 1SD tear film break up time (assessed over the extended eye opening periods) will be determined for:
|
Not provided
Not provided
Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Between 18 and 35 (inclusive) years of age at the time of screening.
They agree not to participate in other clinical research while enrolled on this study.
They have worn the same brand of soft contact lenses at least eight hours per day for at least two days per week over the previous three months.
They own a wearable pair of spectacles if needed for distance vision correction (by self-report).
They typically use digital devices for a minimum of 4 hours per day, 5 days per week.
In a pre-study screening assessment, they must have a CVS-Q score of 4 or less (asymptomatic group) or 6 or greater (symptomatic group).
They can attain a best-corrected logMAR distance visual acuity of at least 0.20 in each eye.
They have spherical contact lens prescription in the range +1.00 to -6.00 DS (based on the calculated ocular refraction).
They have up to maximum of 0.75 DC of refractive astigmatism (based on the calculated ocular refraction).
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Vision Care, Inc. Clinical Trial | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Manchester | Manchester | M13 9PL | United Kingdom |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| at approximately 2-week follow-up |
| Blink completeness | The mean and SD of the maximally closed palpebral aperture (in mm) will be summarized for total blinks, complete blinks and incomplete blinks across the 5 minutes. For total blinks, the mean and SD of maximally closed palpebral aperture will also be determined at 1-minute increments. | at approximately 2-week follow-up |