An observational study in Vision Satisfaction in Bright Light, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 22 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by Johnson & Johnson Vision Care, Inc. · Observational
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.
Johnson & Johnson Vision Care, Inc. is the lead sponsor of 220 studies on the registry; 2 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 101 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Study subjects will be recruited from the clinical site's subject database and/or utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved materials. Within the sites, subjects that have received a prescription of either Intervention within the last 2 months will be invited to participate without regard to any demographic or other ocular features.
Exclusion Criteria:
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™
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
JJVC Marketed Contact Lens
Also known as: TEST Lens
Any reusable spherical silicone hydrogel brand that is approved and marketed in the country conducting the study.
Also known as: CONTROL Lens
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
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
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.
| Milestone | Test | Control |
|---|---|---|
| Started | 88 | 58 |
| Completed | 67 | 46 |
| Not completed | 21 | 12 |
| Withdrew: Withdrew consent during study | 3 | 1 |
| Withdrew: Subject no longer meets eligibility criteria | 1 | 4 |
| Withdrew: Subject withdrawn due to non-compliance to protocol | 11 | 7 |
| Withdrew: Switched to a different type of contact lens due to discomfort and dryness | 1 | 0 |
| Withdrew: Subject was enrolled in error | 2 | 0 |
| Withdrew: Pi confirmed subject was not over 18 when enrolled in study. subject discontinued | 1 | 0 |
| Withdrew: Subject did not like the lenses graduation change | 1 | 0 |
| Withdrew: Subject stopped wearing study lenses after 2 weeks due to dryness | 1 | 0 |
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.
| Responses | Test | Control |
|---|---|---|
| Strongly Agree | 33 | 21 |
| Agree | 33 | 24 |
| Neither Agree Nor Disagree | 10 | 2 |
| Disagree | 2 | 0 |
| Strongly Disagree | 0 | 0 |
| Missing Response (Subject didn't answer the item) | 10 | 7 |
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.
| Responses | Test | Control |
|---|---|---|
| Strongly Agree | 24 | 20 |
| Agree | 38 | 25 |
| Neither Agree Nor Disagree | 7 | 2 |
| Disagree | 2 | 0 |
| Strongly Disagree | 0 | 0 |
| Missing Response (Subject didn't answer the item) | 17 | 7 |
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.
| Responses | Test | Control |
|---|---|---|
| Strongly Agree | 23 | 22 |
| Agree | 29 | 21 |
| Neither Agree Nor Disagree | 4 | 2 |
| Disagree | 3 | 0 |
| Strongly Disagree | 0 | 0 |
| Missing Response (Subject didn't answer the item) | 29 | 9 |
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.
| Responses | Test | Control |
|---|---|---|
| Strongly Agree | 37 | 27 |
| Agree | 36 | 20 |
| Neither Agree Nor Disagree | 3 | 0 |
| Disagree | 1 | 0 |
| Strongly Disagree | 0 | 0 |
| Missing Response (Subject didn't answer the item) | 11 | 7 |
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.
| Responses | Test | Control |
|---|---|---|
| Strongly Agree | 31 | 22 |
| Agree | 35 | 23 |
| Neither Agree Nor Disagree | 5 | 2 |
| Disagree | 0 | 0 |
| Strongly Disagree | 0 | 0 |
| Missing Response (Subject didn't answer the item) | 17 | 7 |
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.
| Responses | Test | Control |
|---|---|---|
| Strongly Agree | 25 | 18 |
| Agree | 30 | 25 |
| Neither Agree Nor Disagree | 1 | 2 |
| Disagree | 3 | 0 |
| Strongly Disagree | 0 | 0 |
| Missing Response (Subject didn't answer the item) | 29 | 9 |
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.
| Responses | Test | Control |
|---|---|---|
| Excellent | 19 | 9 |
| Very Good | 37 | 28 |
| Good | 17 | 9 |
| Fair | 4 | 1 |
| Poor | 0 | 0 |
| Missing Response (Subject didn't answer the item) | 11 | 7 |
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.
| Responses | Test | Control |
|---|---|---|
| Excellent | 27 | 16 |
| Very Good | 25 | 19 |
| Good | 12 | 9 |
| Fair | 6 | 2 |
| Poor | 1 | 1 |
| Missing Response (Subject didn't answer the item) | 17 | 7 |
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.
| Responses | Test | Control |
|---|---|---|
| Excellent | 20 | 10 |
| Very Good | 28 | 23 |
| Good | 8 | 9 |
| Fair | 2 | 2 |
| Poor | 1 | 1 |
| Missing Response (Subject didn't answer the item) | 29 | 9 |
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 responses | Test | Control |
|---|---|---|
| Number of Subjects Experienced the Pulfrich Effect at Least Once | 4 | 1 |
| Number of Subjects Experienced the Pulfrich Effect at 2-Week Evaluation | 4 | 0 |
| Number of Subjects Experienced the Pulfrich Effect at 4-Month Evaluation | 0 | 1 |
| Number of Subjects Experienced the Pulfrich Effect at 12-Month Evaluation | 0 | 0 |
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).
| Number of adverse events | Test | Control |
|---|---|---|
| Serious or Significant Adverse Events | 0 | 0 |
Collected over Throughout the duration of the study; approximately 12 months per subject.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test | 0/88 (0%) | 0/88 (0%) | 0/88 (0%) |
| Control | 0/58 (0%) | 0/58 (0%) | 0/58 (0%) |
The full analysis set including all enrolled subjects (signed consent form) regardless of subsequent withdrawal from study or deviation from protocol.
| Age, Continuous(Years) | Test | Control | Total |
|---|---|---|---|
| Mean | 33.9 ± 11.93 | 31.9 ± 12.09 | 33.1 ± 11.99 |
| Sex: Female, Male(Participants) | Test | Control | Total |
|---|---|---|---|
| Female | 51 | 40 | 91 |
| Male | 37 | 18 | 55 |
| Race and Ethnicity Not Collected(Participants) | Test | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Test | Control | Total |
|---|---|---|---|
| Spain | 64 | 50 | 114 |
| United Kingdom | 24 | 8 | 32 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Vision Care, Inc.