Non-Invasive Assessment of Contact Lens Performance During Use of a Digital Display

Study Overview
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Brief Summary
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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.

Official Title
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Non-Invasive Assessment of Contact Lens Performance During Use of a Digital Display

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: JJVC Marketed Contact Lens


Participation Criteria
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Eligibility Criteria
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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: Currently pregnant or lactating. Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study. They have an ocular disorder which would normally contraindicate contact lens wear. They have had cataract surgery. They have had corneal refractive surgery. They are regularly (once per day or more) using oral or inhaled steroids or anti-inflammatory medications. They are using any topical medications such as eye drops or ointments. Any known hypersensitivity or allergic reaction to sodium fluorescein. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear. See section 9.1 for additional details regarding excluded systemic medications. Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. They have any existing binocular vision anomalies such as strabismus or have been prescribed prisms in their spectacles based on self-report, or in the opinion of the investigator exhibit signs of suppression during binocular vision testing. Any Efron Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which in the investigator's opinion would contraindicate contact lens wear.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: High Sphere<br>Subjects with a spherical refraction between -1.75 DS and -6.00 DS | Device: JJVC Marketed Contact Lens<br>* Acuvue Oasys® 1-Day<br>* Other names: Test 1;|
| Other: Low Sphere<br>Subjects with a spherical refraction between -1.50 DS and +1.00 DS | Device: JJVC Marketed Contact Lens<br>* Acuvue Oasys® 1-Day<br>* Other names: Test 1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: Total blink rate: blinks per minute (all blinks) Complete blink rate: complete blinks per minute. A complete blink will be defined as having a closed palpebral aperture of less than one third of the open palpebral aperture. Incomplete blink rate: incomplete blinks per minute. An incomplete blink will be defined as having a closed palpebral aperture of more than one third of the open palpebral aperture. 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: Total interblink interval: time in seconds between any blinks Complete interblink interval: time in seconds between complete blinks 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: Total interblink interval distribution Complete interblink interval distribution | 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 |