An interventional study of ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY (AO1D) in Visual Acuity, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 5 sites in United States. Open to participants aged 13 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by Johnson & Johnson Vision Care, Inc. · Not applicable, Interventional, and Treatment
This is a multi-site, bilateral, dispensing, non-randomized, uncontrolled, unmasked, single arm study to evaluate visual acuity in neophytes.
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 of the following criteria to be enrolled in the study:
The subject must:
Subject must have a vertex corrected distance sphero-cylindrical refraction in the range such that appropriate spherical lens powers are available for correction in both eyes. The spherical lens powers available in this study are:
a. -1.00 to -6.00 (in 0.25D steps)
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
The subject must not:
Eligible subjects will be fitted bilaterally with the TEST lens for approximately 2 weeks of wear (two 1-week wear periods).
Device: ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY (AO1D)
Test Lens
Incidence (Percentage) of Eyes With Grade 3 or 4 Slit Lamp Findings Related to the Study Lenses
Slit Lamp Findings (SLFs) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). SLF assessment was performed on each subject eye at different study visits (Baseline, unscheduled visits, 1-week follow-up, 2-Week Follow-up, and Final Evaluation). The percentage of eyes with SLF of grade 3 or grade 4 was reported.
Time frame: Up to 2-Week Follow-up
A total of 36 subjects were enrolled in this study. Of those enrolled, 34 subjects were dispensed the study lens, while 1 subject withdrew consent before lens dispensing and 1 subject failed to meet all eligibility criteria. Of those dispensed, 33 subjects completed the study while 1 subject was discontinued.
| Milestone | Test (Senofilcon A C3) |
|---|---|
| Started | 34 |
| Completed | 33 |
| Not completed | 1 |
| Withdrew: Doesn't like wearing contacts | 1 |
Slit Lamp Findings (SLFs) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). SLF assessment was performed on each subject eye at different study visits (Baseline, unscheduled visits, 1-week follow-up, 2-Week Follow-up, and Final Evaluation). The percentage of eyes with SLF of grade 3 or grade 4 was reported.
| Percentage | Test (Senofilcon A C3) |
|---|---|
| Incidence (Percentage) of Eyes With Grade 3 or 4 Slit Lamp Findings Related to the Study Lenses | 0 |
Collected over Throughout the duration of the study; approximately 2-weeks per subject.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test (Senofilcon A C3) | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
All subjects dispensed a study lens.
| Age, Continuous(Years) | Test (Senofilcon A C3) |
|---|---|
| Mean | 23.1 ± 7.59 |
| Sex: Female, Male(Participants) | Test (Senofilcon A C3) |
|---|---|
| Female | 22 |
| Male | 12 |
| Race (NIH/OMB)(Participants) | Test (Senofilcon A C3) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 2 |
| Black or African American | 1 |
| White | 28 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Test (Senofilcon A C3) |
|---|---|
| United States | 34 |
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.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Johnson & Johnson Vision Care, Inc.