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.
Study Type
OBSERVATIONAL
Enrollment
146
JJVC Marketed Contact Lens
Any reusable spherical silicone hydrogel brand that is approved and marketed in the country conducting the study.
Sanchez Rubal Ltd. - Sanchez Bregua
A Coruña, Spain
Sanchez Rubal Ltd - Finisterre
A Coruña, Spain
Vision Satisfaction in Bright Lighting - 2-Week Questionnaire
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.
Time frame: 2-week questionnaire follow-up
Vision Satisfaction in Bright Lighting - 4-Month Questionnaire
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.
Time frame: 4-month questionnaire follow-up
Vision Satisfaction in Bright Lighting - 12-Month Questionnaire
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.
Time frame: 12-month questionnaire follow-up
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Optica Ronda
Almería, Spain
Natural Optics Balaguer
Balaguer, 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
...and 12 more locations
Overall Quality of Vision - 2-Week Questionnaire
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.
Time frame: 2-week questionnaire follow-up
Overall Quality of Vision - 4-Month Questionnaire
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.
Time frame: 4-month questionnaire follow-up
Overall Quality of Vision - 12-Month Questionnaire
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.
Time frame: 12-month questionnaire follow-up
Overall Comfort - 2-Week Questionnaire
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.
Time frame: 2-week questionnaire follow-up
Overall Comfort - 4-Month Questionnaire
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.
Time frame: 4-month questionnaire follow-up
Overall Comfort - 12-Month Questionnaire
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.
Time frame: 12-month questionnaire follow-up
Pulfrich Effect
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.
Time frame: 2-week, 4-month, and 12-month questionnaire follow-up
Serious or Significant Adverse Events
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).
Time frame: Throughout the duration of the study, up to 12 months