An interventional study of Acuvue Oasys 1 Day for Astigmatism with Legacy lidstock and Acuvue Oasys 1 Day for Astigmatism with Amcor laminated lidstock in Ocular Physiology, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Johnson & Johnson Vision Care, Inc. · Not applicable, Interventional, and Treatment
This will be a single-visit, randomized, double-masked, bilateral wear, non-dispensing, 2-sequence × 2-period crossover study to evaluate subject reported ocular symptoms.
413 studies on the registry are indexed under Astigmatism; 55 are open to participants now.
This study's enrollment of 31 is below the median of 55 across 321 interventional studies indexed under Astigmatism.
Browse Astigmatism 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 of the following criteria to be enrolled in the study:
Exclusion Criteria:
The subject must not:
Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to wear two different study lenses, one at a time, over two wear periods (test then control) with a washout period of 15 minutes between wears. During each wear period the lenses will be worn bilaterally for at least one hour in-office.
Device: Acuvue Oasys 1 Day for Astigmatism with Legacy lidstock · Device: Acuvue Oasys 1 Day for Astigmatism with Amcor laminated lidstock
Eligible subjects who are habitual soft contact lens wearers will be randomized into the Control/Test sequence, to wear two different study lenses, one at a time, over two wear periods (control then test) with a washout period of 15 minutes between wears. During each wear period the lenses will be worn bilaterally for at least one hour in-office.
Device: Acuvue Oasys 1 Day for Astigmatism with Legacy lidstock · Device: Acuvue Oasys 1 Day for Astigmatism with Amcor laminated lidstock
CONTROL
TEST
Proportion of Eyes With Moderate or Severe Subject-Reported Ocular Symptoms
Ocular symptoms were assessed using open-ended question. Investigators asked each subject if they experienced any eye symptoms or problems with lens wear when wearing the study lenses. If responded "Yes", then subject characterized each symptom to the following scale for each eye: 0 = Not Applicable or Not Recorded, 1 = Mild and results in little or no interference with lens wear, 2 = Moderate AND/OR occasionally interferes with lens wear, and 3 = Severe AND/OR frequently interferes with lens wear. Investigators classified each subject reported symptom into these categories: Burning/stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision, and Other. The data was dichotomized across all symptoms, where Y=1 if any "moderate" or "severe" ocular symptoms were reported and Y=0 otherwise. The proportion of eyes with any "moderate" or "severe" ocular symptoms was reported for each lens.
Time frame: Up to 1-Hour Follow-Up
A total of 31 subjects were enrolled in this study. Of those enrolled, 30 subjects were dispensed at least one study lens, while 1 subject failed to meet all eligibility criteria. Of those dispensed, all 30 subjects completed the study.
| Milestone | Test/Control | Control/Test |
|---|---|---|
| Started | 15 | 15 |
| Completed | 15 | 15 |
| Not completed | 0 | 0 |
| Milestone | Test/Control | Control/Test |
|---|---|---|
| Started | 15 | 15 |
| Completed | 15 | 15 |
| Not completed | 0 | 0 |
Ocular symptoms were assessed using open-ended question. Investigators asked each subject if they experienced any eye symptoms or problems with lens wear when wearing the study lenses. If responded "Yes", then subject characterized each symptom to the following scale for each eye: 0 = Not Applicable or Not Recorded, 1 = Mild and results in little or no interference with lens wear, 2 = Moderate AND/OR occasionally interferes with lens wear, and 3 = Severe AND/OR frequently interferes with lens wear. Investigators classified each subject reported symptom into these categories: Burning/stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision, and Other. The data was dichotomized across all symptoms, where Y=1 if any "moderate" or "severe" ocular symptoms were reported and Y=0 otherwise. The proportion of eyes with any "moderate" or "severe" ocular symptoms was reported for each lens.
| Proportion of eyes | Test | Control |
|---|---|---|
| 15-Minute Follow-up | 0 | 0 |
| 1-Hour Follow-up | 0 | 0 |
Collected over Throughout the duration of the study; approximately 1-day per subject.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Control | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
All subjects dispensed a study lens.
| Age, Continuous(Years) | Dispensed Subjects |
|---|---|
| Mean | 29.5 ± 6.43 |
| Sex: Female, Male(Participants) | Dispensed Subjects |
|---|---|
| Female | 21 |
| Male | 9 |
| Race/Ethnicity, Customized(Participants) | Dispensed Subjects |
|---|---|
| Asian | 5 |
| Black or African American | 3 |
| Native Hawaiian or Other Pacific Islander | 1 |
| White | 21 |
| Region of Enrollment(Participants) | Dispensed Subjects |
|---|---|
| United States | 30 |
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.