An interventional study of ACUVUE® OASYS with Transitions™ in Visual Acuity, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 5 sites in United States. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-10.
Sponsored by Johnson & Johnson Vision Care, Inc. · Not applicable, Interventional, and Treatment
This is a single-masked, dispensing clinical trial. A total of approximately 48 myopic and 32 hyperopic eligible subjects will be targeted to complete the study. Subjects will be fit in the study lens, optimized if required and worn for approximately 2 weeks. Subjects will then have a washout period of approximately 1 week and be refit in the lenses and be dispensed for an additional 2 weeks of wear.
324 studies on the registry are indexed under Presbyopia; 33 are open to participants now.
This study's enrollment of 91 is above the median of 61 across 265 interventional studies indexed under Presbyopia.
Browse Presbyopia studies →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.
Potential subjects must satisfy all the following criteria to be enrolled in the study:
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Eligible subjects between the ages of 40 to 70 years of age and habitual wearers of soft contact lenses will be fitted with the study lens for two wearing cycles.
Device: ACUVUE® OASYS with Transitions™
JJVC Marketed Contact Lens
Vision Scores
Vision Scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Time frame: 2-Week Follow-up
Visual Performance (logMAR)
Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters), intermediate (64 centimeters) and near (40 centimeters) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be etween 7.3 and 7.9 EV (394-597 lux). For Distance (4 meters), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64 cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Time frame: 2-Week Follow-up
CLUE Vision Comparison Between First Wearing Cycle and Second Wearing Cycle
Vision Scores wwere assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Time frame: Up to 2-Week Follow-up
A total of 91 subjects were enrolled in this study. Of those enrolled, 86 subjects were dispensed a least one study lens while 5 subjects failed to meet all eligibility criteria. Of those dispensed, 79 subjects completed the study, while 7 were discontinued.
| Milestone | Test |
|---|---|
| Started | 86 |
| Completed | 80 |
| Not completed | 6 |
| Withdrew: Time required to complete last two study visits exceeds study deadline | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Lens discomfort | 2 |
| Withdrew: Unsatisfactory visual response due to test article | 1 |
| Milestone | Test |
|---|---|
| Started | 80 |
| Completed | 79 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
Vision Scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
| Units on a Scale | Test (First Wearing Cycle) | Test (Second Wearing Cycle) |
|---|---|---|
| Vision Scores | 59.38 ± 19.700 | 56.19 ± 23.387 |
Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters), intermediate (64 centimeters) and near (40 centimeters) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be etween 7.3 and 7.9 EV (394-597 lux). For Distance (4 meters), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64 cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
| logMAR | Test (First Wearing Cycle) | Test (Second Wearing Cycle) |
|---|---|---|
| Distance (4 Meter) | -0.08 ± 0.097 | -0.08 ± 0.100 |
| Intermediate (64 CM) | -0.02 ± 0.096 | -0.03 ± 0.095 |
| Near (40 CM) | 0.04 ± 0.085 | 0.02 ± 0.081 |
Vision Scores wwere assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
| Units on a Scale | Test (First Wearing Cycle) | Test (Second Wearing Cycle) |
|---|---|---|
| CLUE Vision Comparison Between First Wearing Cycle and Second Wearing Cycle | 59.38 ± 19.700 | 56.19 ± 23.387 |
Collected over Throughout the entire duration of the study. Approximately 1 month per subject.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test | 0/86 (0%) | 1/86 (1.2%) | 0/86 (0%) |
| Event | Test |
|---|---|
| Chest PainCardiac disorders | 1/86 |
| Age, Continuous(Years) | Test |
|---|---|
| Mean | 54.8 ± 6.24 |
| Sex: Female, Male(Participants) | Test |
|---|---|
| Female | 69 |
| Male | 17 |
| Race (NIH/OMB)(Participants) | Test |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 5 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 13 |
| White | 67 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Test |
|---|---|
| United States | 86 |
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
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Johnson & Johnson Vision Care, Inc.