ACUVUE® OASYS With Transitions™ Light Intelligent Technology™ Clinical Performance Registry
- Conditions
- Vision Satisfaction in Bright Light
- Interventions
- Device: ACUVUE® OASYS with Transitions™Device: Silicone Hydrogel Contact Lens
- Registration Number
- NCT04116736
- Lead Sponsor
- Johnson & Johnson Vision Care, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description TEST Lens ACUVUE® OASYS with Transitions™ 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. CONTROL Lens Silicone Hydrogel Contact Lens 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.
- Primary Outcome Measures
Name Time Method Vision Satisfaction in Bright Lighting - 2-Week Questionnaire 2-week questionnaire follow-up Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement "I am satisfied with the quality of my vision in bright lighting with these contact lenses" using a 5-point agreement Likert scale (Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree). In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the primary endpoint data summary. The number of missing responses in each lens group was reported.
Vision Satisfaction in Bright Lighting - 4-Month Questionnaire 4-month questionnaire follow-up Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement "I am satisfied with the quality of my vision in bright lighting with these contact lenses" using a 5-point agreement Likert scale (Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree). In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the primary endpoint data summary. The number of missing responses in each lens group was reported.
Vision Satisfaction in Bright Lighting - 12-Month Questionnaire 12-month questionnaire follow-up Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement "I am satisfied with the quality of my vision in bright lighting with these contact lenses" using a 5-point agreement Likert scale (Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree). In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the primary endpoint data summary.
- Secondary Outcome Measures
Name Time Method Serious or Significant Adverse Events Throughout the duration of the study, up to 12 months A serious adverse event is any untoward medical occurrence that is potentially sight-threatening, requires hospitalization, results in persistent or significant disability / incapacity, or requires intervention to prevent permanent damage.
Significant adverse events are usually symptomatic and warrant discontinuation (temporary or permanent) of the test article (excluding serious adverse events).Overall Quality of Vision - 2-Week Questionnaire 2-week questionnaire follow-up Overall quality of vision was assessed subjectively using the item "I am satisfied with the overall quality of my vision with these contact lenses". The item used a 5-point agreement scale: Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported.
Overall Quality of Vision - 4-Month Questionnaire 4-month questionnaire follow-up Overall quality of vision was assessed subjectively using the item "I am satisfied with the overall quality of my vision with these contact lenses". The item used a 5-point agreement scale: Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported.
Overall Quality of Vision - 12-Month Questionnaire 12-month questionnaire follow-up Overall quality of vision was assessed subjectively using the item "I am satisfied with the overall quality of my vision with these contact lenses". The item used a 5-point agreement scale: Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported.
Overall Comfort - 2-Week Questionnaire 2-week questionnaire follow-up Overall comfort was assessed using the item "How would you rate the overall comfort of these contact lenses?". The item used the 5-point excellence scale, Excellent, Very Good, Good, Fair, and Poor. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported.
Overall Comfort - 4-Month Questionnaire 4-month questionnaire follow-up Overall comfort was assessed using the item "How would you rate the overall comfort of these contact lenses?". The item used the 5-point excellence scale, Excellent, Very Good, Good, Fair, and Poor. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported.
Overall Comfort - 12-Month Questionnaire 12-month questionnaire follow-up Overall comfort was assessed using the item "How would you rate the overall comfort of these contact lenses?". The item used the 5-point excellence scale, Excellent, Very Good, Good, Fair, and Poor. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported.
Pulfrich Effect 2-week, 4-month, and 12-month questionnaire follow-up Pulfrich effect was assessed subjectively using the item "While wearing these lenses, my depth perception of moving objects has NOT been impacted". Subjects who disagreed or strongly disagreed with the statement were considered to have experienced the Pulfrich effect. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary.
Trial Locations
- Locations (20)
Optica Ronda
🇪🇸Almeria, Spain
Natural Optics Balaguer
🇪🇸Balaguer, Spain
Sanchez Rubal Ltd. - Sanchez Bregua
🇪🇸La Coruna, Spain
Sanchez Rubal Ltd - Finisterre
🇪🇸La Coruna, Spain
Centro Optico Raga
🇪🇸Linares, Spain
Centro Optico Montero
🇪🇸Madrid, Spain
Centro Boston de Optometria
🇪🇸Madrid, Spain
Cirugia Ocular de Madrid
🇪🇸Madrid, Spain
Opticalia Real Villa
🇪🇸Madrid, Spain
Opticas ClaraVision
🇪🇸Ontinyent, Spain
Scroll for more (10 remaining)Optica Ronda🇪🇸Almeria, Spain