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 nu
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 nu
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.
Strongly Agree
Group
Value
95% CI
Test
23
Control
22
Agree
Group
Value
95% CI
Test
29
Control
21
Neither Agree Nor Disagree
Group
Value
95% CI
Test
4
Control
2
Disagree
Group
Value
95% CI
Test
3
Control
0
Strongly Disagree
Group
Value
95% CI
Test
0
Control
0
Missing Response (Subject didn't answer the item)
Group
Value
95% CI
Test
29
Control
9
Overall Quality of Vision - 2-Week QuestionnaireSecondary· 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.
Strongly Agree
Group
Value
95% CI
Test
37
Control
27
Agree
Group
Value
95% CI
Test
36
Control
20
Neither Agree Nor Disagree
Group
Value
95% CI
Test
3
Control
0
Disagree
Group
Value
95% CI
Test
1
Control
0
Strongly Disagree
Group
Value
95% CI
Test
0
Control
0
Missing Response (Subject didn't answer the item)
Group
Value
95% CI
Test
11
Control
7
Overall Quality of Vision - 4-Month QuestionnaireSecondary· 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.
Strongly Agree
Group
Value
95% CI
Test
31
Control
22
Agree
Group
Value
95% CI
Test
35
Control
23
Neither Agree Nor Disagree
Group
Value
95% CI
Test
5
Control
2
Disagree
Group
Value
95% CI
Test
0
Control
0
Strongly Disagree
Group
Value
95% CI
Test
0
Control
0
Missing Response (Subject didn't answer the item)
Group
Value
95% CI
Test
17
Control
7
Overall Quality of Vision - 12-Month QuestionnaireSecondary· 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 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 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 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.
Excellent
Group
Value
95% CI
Test
20
Control
10
Very Good
Group
Value
95% CI
Test
28
Control
23
Good
Group
Value
95% CI
Test
8
Control
9
Fair
Group
Value
95% CI
Test
2
Control
2
Poor
Group
Value
95% CI
Test
1
Control
1
Missing Response (Subject didn't answer the item)
Group
Value
95% CI
Test
29
Control
9
Pulfrich EffectSecondary· 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.
Number of Subjects Experienced the Pulfrich Effect at Least Once
Group
Value
95% CI
Test
4
Control
1
Number of Subjects Experienced the Pulfrich Effect at 2-Week Evaluation
Group
Value
95% CI
Test
4
Control
0
Number of Subjects Experienced the Pulfrich Effect at 4-Month Evaluation
Group
Value
95% CI
Test
0
Control
1
Number of Subjects Experienced the Pulfrich Effect at 12-Month Evaluation
Group
Value
95% CI
Test
0
Control
0
Serious or Significant Adverse EventsSecondary· 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).
Group
Value
95% CI
Test
0
Control
0
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johnson & Johnson Vision Care, Inc.
Last refreshed: 23 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04116736.