The Effects of Contact Lenses With UV/HEV-Filter on Visual Function

Study Overview
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Brief Summary
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This is a 2-phase, single-site, non-dispensing, randomized, controlled, double-masked, 2x2 crossover study to objectively measure potential benefits of a new UV/HEV filter using psychophysical testing techniques.

Official Title
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The Effects of Contact Lenses With UV/HEV-Filter on Visual Function

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: ACUVUE OASYS 1-Day
* Device: ACUVUE OASYS MAX 1-Day
* Device: ACUVUE OASYS Multifocal
* Device: ACUVUE OASYS MAX 1-Day Multifocal
* Device: ACUVUE OASYS 1-Day for Astigmatism
* Device: senofilcon A based contact lens (toric) with new UV/HEV filter


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. Be between 18 and 70 (inclusive) years of age at the time of screening. By self-report, habitually wear soft contact lenses (sphere, multifocal, toric) in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days. If applicable, those subjects receiving the spherical lenses will need a vertex-corrected distance refraction within the range of -1.00 through -6.00 DS If applicable, those subjects receiving the multifocal lenses will need a vertex-corrected distance refraction within the range of -1.00 through -6.00 DS If applicable, those subjects receiving the toric lenses will need a vertex-corrected distance refraction within the range of -1.50 through -4.00 DS, -0.625 through -1.625 DC, and cylinder axes: 80/90/100, 170/180/10 The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: The subject must not: Be currently pregnant or lactating. Be currently using any ocular medications or have any ocular infection of any type. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that the investigator believes might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months. Be currently wearing lenses in an extended wear modality. Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site. (Phase 2 only): Have participated in Phase 1 of the study. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that the investigator believes might contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). Have a history of strabismus or amblyopia. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sphere TEST/CONTROL<br>Eligible subjects who are habitual wearers of soft contact lenses that receive the sphere lenses will be randomized into the sphere TEST/CONTROL sequence. | Device: ACUVUE OASYS 1-Day<br>* Sphere CONTROL<br>Device: ACUVUE OASYS MAX 1-Day<br>* Sphere TEST<br>|
| Experimental: Sphere CONTROL/TEST<br>Eligible subjects who are habitual wearers of soft contact lenses that receive the sphere lenses will be randomized into the sphere CONTROL/TEST sequence. | Device: ACUVUE OASYS 1-Day<br>* Sphere CONTROL<br>Device: ACUVUE OASYS MAX 1-Day<br>* Sphere TEST<br>|
| Experimental: Multifocal TEST/CONTROL<br>Eligible subjects who are habitual wearers of soft contact lenses that receive the multifocal lenses will be randomized into the multifocal TEST/CONTROL sequence. | Device: ACUVUE OASYS Multifocal<br>* Multifocal CONTROL<br>Device: ACUVUE OASYS MAX 1-Day Multifocal<br>* Multifocal TEST<br>|
| Experimental: Multifocal CONTROL/TEST<br>Eligible subjects who are habitual wearers of soft contact lenses that receive the multifocal lenses will be randomized into the multifocal CONTROL/TEST sequence. | Device: ACUVUE OASYS Multifocal<br>* Multifocal CONTROL<br>Device: ACUVUE OASYS MAX 1-Day Multifocal<br>* Multifocal TEST<br>|
| Experimental: Toric TEST/CONTROL<br>Eligible subjects who are habitual wearers of soft contact lenses that receive the toric lenses will be randomized into the toric TEST/CONTROL sequence. | Device: ACUVUE OASYS 1-Day for Astigmatism<br>* Toric CONTROL<br>Device: senofilcon A based contact lens (toric) with new UV/HEV filter<br>* Toric TEST<br>|
| Experimental: Toric CONTROL/TEST<br>Eligible subjects who are habitual wearers of soft contact lenses that receive the toric lenses will be randomized into the toric CONTROL/TEST sequence. | Device: ACUVUE OASYS 1-Day for Astigmatism<br>* Toric CONTROL<br>Device: senofilcon A based contact lens (toric) with new UV/HEV filter<br>* Toric TEST<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Range for Multifocal Wearers | Visual range will be tested for multifocal wearers binocularly at 8 cycles per degree in units of log relative energy (LRE) between 0.00-10.00. Visual range is defined as the log relative energy of simulated haze needed to obscure an otherwise high contrast grating target. | up to 2-week follow-up | 
| Visual Range for Sphere Wearers | Visual range will be tested for sphere wearers binocularly at 8 cycles per degree in units of log relative energy (LRE) between 0.00-10.00. Visual range is defined as the log relative energy of simulated haze needed to obscure an otherwise high contrast grating target. | up to 2-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motion Detection | Motion detection will be tested for spherical wearers binocularly in units of mm between 0.00-700.00. Motion detection is defined as the distance needed (in mm) to determine that a test light has moved from a standard position. | up to 2-week follow-up | 
| Brightness Perception | Brightness perception will be tested for multifocal wearers binocularly in units of log relative energy (LRE) between 0.00-10.00. Brightness perception is defined as the log relative energy needed to match a standard stimulus to a natural scene, across 10 different projected scenes. | up to 2-week follow-up |