Trial Outcomes & Findings for ACUVUE® OASYS With Transitions™ Light Intelligent Technology™ Clinical Performance Registry (NCT NCT04116736)
NCT ID: NCT04116736
Last Updated: 2025-05-23
Results Overview
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.
COMPLETED
146 participants
2-week questionnaire follow-up
2025-05-23
Participant Flow
A total of 146 subjects were enrolled in this study. All 146 subjects (88 in the Test group and 58 in the Control group) were deemed eligible at the screening visit. In the Control group 4 subjects were later identified as ineligible (enrolled in error), as they were wearing ineligible Control lenses. Of those enrolled, 113 subjects completed the study while 33 subjects were discontinued.
Participant milestones
| Measure |
Test
Patients who had recently been fitted with ACUVUE® OASYS with Transitions™
|
Control
Patients who had recently been fitted with spherical non-photochromic reusable marketed silicone hydrogel contact lenses of any brand.
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
58
|
|
Overall Study
COMPLETED
|
67
|
46
|
|
Overall Study
NOT COMPLETED
|
21
|
12
|
Reasons for withdrawal
| Measure |
Test
Patients who had recently been fitted with ACUVUE® OASYS with Transitions™
|
Control
Patients who had recently been fitted with spherical non-photochromic reusable marketed silicone hydrogel contact lenses of any brand.
|
|---|---|---|
|
Overall Study
Withdrew consent during study
|
3
|
1
|
|
Overall Study
Subject no longer meets eligibility criteria
|
1
|
4
|
|
Overall Study
Subject withdrawn due to non-compliance to protocol
|
11
|
7
|
|
Overall Study
Switched to a different type of contact lens due to discomfort and dryness
|
1
|
0
|
|
Overall Study
Subject was enrolled in error
|
2
|
0
|
|
Overall Study
PI confirmed subject was not over 18 when enrolled in study. Subject discontinued
|
1
|
0
|
|
Overall Study
Subject did not like the lenses graduation change
|
1
|
0
|
|
Overall Study
Subject stopped wearing study lenses after 2 weeks due to dryness
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Test
n=88 Participants
Patients who had recently been fitted with ACUVUE® OASYS with Transitions™
|
Control
n=58 Participants
Patients who had recently been fitted with spherical non-photochromic reusable marketed silicone hydrogel contact lenses of any brand.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.9 Years
STANDARD_DEVIATION 11.93 • n=88 Participants
|
31.9 Years
STANDARD_DEVIATION 12.09 • n=58 Participants
|
33.1 Years
STANDARD_DEVIATION 11.99 • n=146 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=88 Participants
|
40 Participants
n=58 Participants
|
91 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=88 Participants
|
18 Participants
n=58 Participants
|
55 Participants
n=146 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Spain
|
64 Participants
n=88 Participants
|
50 Participants
n=58 Participants
|
114 Participants
n=146 Participants
|
|
Region of Enrollment
United Kingdom
|
24 Participants
n=88 Participants
|
8 Participants
n=58 Participants
|
32 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: 2-week questionnaire follow-upPopulation: All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing responses was reported for each endpoint at each timepoint.
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.
Outcome measures
| Measure |
Test
n=88 Participants
Subjects that wore the Test lens during the study.
|
Control
n=54 Participants
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
Vision Satisfaction in Bright Lighting - 2-Week Questionnaire
Strongly Agree
|
33 Responses
|
21 Responses
|
|
Vision Satisfaction in Bright Lighting - 2-Week Questionnaire
Agree
|
33 Responses
|
24 Responses
|
|
Vision Satisfaction in Bright Lighting - 2-Week Questionnaire
Neither Agree Nor Disagree
|
10 Responses
|
2 Responses
|
|
Vision Satisfaction in Bright Lighting - 2-Week Questionnaire
Disagree
|
2 Responses
|
0 Responses
|
|
Vision Satisfaction in Bright Lighting - 2-Week Questionnaire
Strongly Disagree
|
0 Responses
|
0 Responses
|
|
Vision Satisfaction in Bright Lighting - 2-Week Questionnaire
Missing Response (Subject didn't answer the item)
|
10 Responses
|
7 Responses
|
PRIMARY outcome
Timeframe: 4-month questionnaire follow-upPopulation: all subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing responses was reported for each endpoint at each timepoint.
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.
Outcome measures
| Measure |
Test
n=88 Participants
Subjects that wore the Test lens during the study.
|
Control
n=54 Participants
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
Vision Satisfaction in Bright Lighting - 4-Month Questionnaire
Strongly Agree
|
24 Responses
|
20 Responses
|
|
Vision Satisfaction in Bright Lighting - 4-Month Questionnaire
Agree
|
38 Responses
|
25 Responses
|
|
Vision Satisfaction in Bright Lighting - 4-Month Questionnaire
Neither Agree Nor Disagree
|
7 Responses
|
2 Responses
|
|
Vision Satisfaction in Bright Lighting - 4-Month Questionnaire
Disagree
|
2 Responses
|
0 Responses
|
|
Vision Satisfaction in Bright Lighting - 4-Month Questionnaire
Strongly Disagree
|
0 Responses
|
0 Responses
|
|
Vision Satisfaction in Bright Lighting - 4-Month Questionnaire
Missing Response (Subject didn't answer the item)
|
17 Responses
|
7 Responses
|
PRIMARY outcome
Timeframe: 12-month questionnaire follow-upPopulation: All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing responses was reported for each endpoint at each timepoint.
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.
Outcome measures
| Measure |
Test
n=88 Participants
Subjects that wore the Test lens during the study.
|
Control
n=54 Participants
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
Vision Satisfaction in Bright Lighting - 12-Month Questionnaire
Strongly Agree
|
23 Responses
|
22 Responses
|
|
Vision Satisfaction in Bright Lighting - 12-Month Questionnaire
Agree
|
29 Responses
|
21 Responses
|
|
Vision Satisfaction in Bright Lighting - 12-Month Questionnaire
Neither Agree Nor Disagree
|
4 Responses
|
2 Responses
|
|
Vision Satisfaction in Bright Lighting - 12-Month Questionnaire
Disagree
|
3 Responses
|
0 Responses
|
|
Vision Satisfaction in Bright Lighting - 12-Month Questionnaire
Strongly Disagree
|
0 Responses
|
0 Responses
|
|
Vision Satisfaction in Bright Lighting - 12-Month Questionnaire
Missing Response (Subject didn't answer the item)
|
29 Responses
|
9 Responses
|
SECONDARY outcome
Timeframe: 2-week questionnaire follow-upPopulation: All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing data was reported for each endpoint at each timepoint.
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.
Outcome measures
| Measure |
Test
n=88 Participants
Subjects that wore the Test lens during the study.
|
Control
n=54 Participants
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
Overall Quality of Vision - 2-Week Questionnaire
Strongly Agree
|
37 Responses
|
27 Responses
|
|
Overall Quality of Vision - 2-Week Questionnaire
Agree
|
36 Responses
|
20 Responses
|
|
Overall Quality of Vision - 2-Week Questionnaire
Neither Agree Nor Disagree
|
3 Responses
|
0 Responses
|
|
Overall Quality of Vision - 2-Week Questionnaire
Disagree
|
1 Responses
|
0 Responses
|
|
Overall Quality of Vision - 2-Week Questionnaire
Strongly Disagree
|
0 Responses
|
0 Responses
|
|
Overall Quality of Vision - 2-Week Questionnaire
Missing Response (Subject didn't answer the item)
|
11 Responses
|
7 Responses
|
SECONDARY outcome
Timeframe: 4-month questionnaire follow-upPopulation: All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing data was reported for each endpoint at each timepoint.
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.
Outcome measures
| Measure |
Test
n=88 Participants
Subjects that wore the Test lens during the study.
|
Control
n=54 Participants
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
Overall Quality of Vision - 4-Month Questionnaire
Strongly Agree
|
31 Responses
|
22 Responses
|
|
Overall Quality of Vision - 4-Month Questionnaire
Agree
|
35 Responses
|
23 Responses
|
|
Overall Quality of Vision - 4-Month Questionnaire
Neither Agree Nor Disagree
|
5 Responses
|
2 Responses
|
|
Overall Quality of Vision - 4-Month Questionnaire
Disagree
|
0 Responses
|
0 Responses
|
|
Overall Quality of Vision - 4-Month Questionnaire
Strongly Disagree
|
0 Responses
|
0 Responses
|
|
Overall Quality of Vision - 4-Month Questionnaire
Missing Response (Subject didn't answer the item)
|
17 Responses
|
7 Responses
|
SECONDARY outcome
Timeframe: 12-month questionnaire follow-upPopulation: All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing data was reported for each endpoint at each timepoint.
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.
Outcome measures
| Measure |
Test
n=88 Participants
Subjects that wore the Test lens during the study.
|
Control
n=54 Participants
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
Overall Quality of Vision - 12-Month Questionnaire
Strongly Agree
|
25 Responses
|
18 Responses
|
|
Overall Quality of Vision - 12-Month Questionnaire
Agree
|
30 Responses
|
25 Responses
|
|
Overall Quality of Vision - 12-Month Questionnaire
Neither Agree Nor Disagree
|
1 Responses
|
2 Responses
|
|
Overall Quality of Vision - 12-Month Questionnaire
Disagree
|
3 Responses
|
0 Responses
|
|
Overall Quality of Vision - 12-Month Questionnaire
Strongly Disagree
|
0 Responses
|
0 Responses
|
|
Overall Quality of Vision - 12-Month Questionnaire
Missing Response (Subject didn't answer the item)
|
29 Responses
|
9 Responses
|
SECONDARY outcome
Timeframe: 2-week questionnaire follow-upPopulation: All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing data was reported for each endpoint at each timepoint.
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.
Outcome measures
| Measure |
Test
n=88 Participants
Subjects that wore the Test lens during the study.
|
Control
n=54 Participants
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
Overall Comfort - 2-Week Questionnaire
Excellent
|
19 Responses
|
9 Responses
|
|
Overall Comfort - 2-Week Questionnaire
Very Good
|
37 Responses
|
28 Responses
|
|
Overall Comfort - 2-Week Questionnaire
Good
|
17 Responses
|
9 Responses
|
|
Overall Comfort - 2-Week Questionnaire
Fair
|
4 Responses
|
1 Responses
|
|
Overall Comfort - 2-Week Questionnaire
Poor
|
0 Responses
|
0 Responses
|
|
Overall Comfort - 2-Week Questionnaire
Missing Response (Subject didn't answer the item)
|
11 Responses
|
7 Responses
|
SECONDARY outcome
Timeframe: 4-month questionnaire follow-upPopulation: All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing data was reported for each endpoint at each timepoint.
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.
Outcome measures
| Measure |
Test
n=88 Participants
Subjects that wore the Test lens during the study.
|
Control
n=54 Participants
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
Overall Comfort - 4-Month Questionnaire
Excellent
|
27 Responses
|
16 Responses
|
|
Overall Comfort - 4-Month Questionnaire
Very Good
|
25 Responses
|
19 Responses
|
|
Overall Comfort - 4-Month Questionnaire
Good
|
12 Responses
|
9 Responses
|
|
Overall Comfort - 4-Month Questionnaire
Fair
|
6 Responses
|
2 Responses
|
|
Overall Comfort - 4-Month Questionnaire
Poor
|
1 Responses
|
1 Responses
|
|
Overall Comfort - 4-Month Questionnaire
Missing Response (Subject didn't answer the item)
|
17 Responses
|
7 Responses
|
SECONDARY outcome
Timeframe: 12-month questionnaire follow-upPopulation: All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing data was reported for each endpoint at each timepoint.
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.
Outcome measures
| Measure |
Test
n=88 Participants
Subjects that wore the Test lens during the study.
|
Control
n=54 Participants
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
Overall Comfort - 12-Month Questionnaire
Excellent
|
20 Responses
|
10 Responses
|
|
Overall Comfort - 12-Month Questionnaire
Very Good
|
28 Responses
|
23 Responses
|
|
Overall Comfort - 12-Month Questionnaire
Good
|
8 Responses
|
9 Responses
|
|
Overall Comfort - 12-Month Questionnaire
Fair
|
2 Responses
|
2 Responses
|
|
Overall Comfort - 12-Month Questionnaire
Poor
|
1 Responses
|
1 Responses
|
|
Overall Comfort - 12-Month Questionnaire
Missing Response (Subject didn't answer the item)
|
29 Responses
|
9 Responses
|
SECONDARY outcome
Timeframe: 2-week, 4-month, and 12-month questionnaire follow-upPopulation: All subjects in the full analysis population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. There were 58 subjects in Full Analysis population, but 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 secondary endpoint data summary.
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.
Outcome measures
| Measure |
Test
n=88 Participants
Subjects that wore the Test lens during the study.
|
Control
n=54 Participants
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
Pulfrich Effect
Number of Subjects Experienced the Pulfrich Effect at Least Once
|
4 Number of responses
|
1 Number of responses
|
|
Pulfrich Effect
Number of Subjects Experienced the Pulfrich Effect at 2-Week Evaluation
|
4 Number of responses
|
0 Number of responses
|
|
Pulfrich Effect
Number of Subjects Experienced the Pulfrich Effect at 4-Month Evaluation
|
0 Number of responses
|
1 Number of responses
|
|
Pulfrich Effect
Number of Subjects Experienced the Pulfrich Effect at 12-Month Evaluation
|
0 Number of responses
|
0 Number of responses
|
SECONDARY outcome
Timeframe: Throughout the duration of the study, up to 12 monthsPopulation: The full analysis set including all enrolled subjects (signed consent form) regardless of subsequent withdrawal from study or deviation from protocol.
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).
Outcome measures
| Measure |
Test
n=88 Participants
Subjects that wore the Test lens during the study.
|
Control
n=58 Participants
Subjects that wore the Control lens during the study.
|
|---|---|---|
|
Serious or Significant Adverse Events
|
0 Number of adverse events
|
0 Number of adverse events
|
Adverse Events
Test
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Graeme Young
Johnson & Johnson Vision Care (JJVC)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place