ACUVUE® OASYS With Transitions™ Light Intelligent Technology™ Clinical Performance Registry

Study Overview
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Brief Summary
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This registry study is a one-year, one-visit, observational, prospective, open-label, two-arm, multi-center, multi-national, post-market study of approximately 300 patients who have recently been fitted with the ACUVUE® OASYS with Transitions™ and approximately 300 patients who have recently been fitted with spherical nonphotochromic reusable marketed silicone hydrogel contact lenses (of any brand). Eligible subjects will be asked to complete a Patient Registration Questionnaire several times throughout the year.

Official Title
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ACUVUE® OASYS With Transitions™ Light Intelligent Technology™ Clinical Performance Registry

Conditions
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Vision Satisfaction in Bright Light

Intervention / Treatment
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* Device: ACUVUE® OASYS with Transitions™
* Device: Silicone Hydrogel 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: Contact lens neophytes or those who have recently (i.e. within last 2 months) begun the use of a new lens type and have purchased a supply of lenses. A minimum age of 18 years, with no maximum age. The registrant must read and sign the Informed Consent form. The registrant must appear able and willing to adhere to the instructions set forth in this clinical protocol. Exclusion Criteria: - Potential subjects who meet any of the following criteria will be excluded from participating in the study: Current participant in another research study. Employee or relative of site, or family member of Recruiting Practitioner or Johnson & Johnson. Non-spherical contact lens wearers, i.e. toric or multifocal lenses.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TEST Lens<br>Eligible subjects that are at least 18 years old, who have been recently fitted (within the last 2 months) with the ACUVUE® OASYS with Transitions™ will be asked to complete follow-up assessments performed online at approximately 2-weeks, 4-months, and 12-months following Visit 1. | Device: ACUVUE® OASYS with Transitions™<br>* JJVC Marketed Contact Lens<br>* Other names: TEST Lens;|
| CONTROL Lens<br>Eligible subjects that are at least 18 years old, who have been recently fitted (within the last 2 months) with spherical non-photochromic reusable marketed silicone hydrogel contact lenses (of any brand) will be asked to complete follow-up assessments performed online at approximately 2-weeks, 4-months, and 12-months following Visit 1. | Device: Silicone Hydrogel Contact Lens<br>* Any reusable spherical silicone hydrogel brand that is approved and marketed in the country conducting the study.<br>* Other names: CONTROL Lens;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vision Satisfaction in Bright Lighting | Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement I was satisfied with the quality of my vision in bright lighting with these contact lenses using a 5-point agreement Likert scale (1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree). | up to 12-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall quality of vision | This will be assessed subjectively using the item I am satisfied with the overall quality of my vision with these contact lenses. The item uses a 5-point agreement scale (1: Strongly Disagree to 5: Strongly Agree). | up to 12-month follow-up | 
| Pulfrich Effect | This will be assessed subjectively using the item While wearing these lenses, my depth perception of moving objects has NOT been impacted. Subjects who disagree or strongly disagree with the statement will be considered to have experienced the Pulfrich effect. | up to 12-month follow-up | 
| Overall comfort | This will be assessed using the item How would you rate the overall comfort of these contact lenses?. The item uses the 5-point satisfaction scale, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. | up to 12-month follow-up | 
| Reported serious and significant ocular adverse events | Incidence rate serious and significant ocular adverse events during the study period will be calculated (in 100 patient-year) using all available data from the entire study. | up to 12-month follow-up |