An interventional study of Test Lens and Control Lens in Astigmatism, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 12 sites in United States. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Johnson & Johnson Vision Care, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment
This is a prospective, multi-site, 4-visit, bilateral, dispensing, randomized, controlled, double-masked, 2x2 crossover study to evaluate subjective comfort, overall opinion and end of day comfort following wear of two different contact lenses.
417 studies on the registry are indexed under Astigmatism; 50 are open to participants now.
This study's enrollment of 134 is above the median of 55 across 325 interventional studies indexed under Astigmatism.
Browse Astigmatism studies →Johnson & Johnson Vision Care, Inc. is the lead sponsor of 221 studies on the registry; 1 is open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 103 (93%) 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:
In both eyes, have refractive error suitable for correction with the range of toric contact lens powers available in this study:
6.1 Sphere powers (DS) -1.50 through -4.00 (inclusive) in 0.25 steps 6.2 Cylinder powers (DC) -0.75 and -1.25 6.3 Axes (°) 170, 180, 10, 80, 90 and 100
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
The subject must not:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible subjects will be randomized into the Test/Control sequence, to wear each study lens (Test lens and Control lens) in a daily disposable modality for approximately one week with a washout period of one week between study lens wear periods.
Device: Test Lens · Device: Control Lens
Eligible subjects will be randomized into the Control/Test sequence, to wear each study lens (Control lens and Test lens) in a daily disposable modality for approximately one week with a washout period of one week between study lens wear periods.
Device: Test Lens · Device: Control Lens
ACUVUE® OASYS MAX 1-Day for ASTIGMATISM (AOM1DfA).
Alcon DAILIES TOTAL1® for Astigmatism Contact Lenses (DT1fA).
Long Lasting Comfort
Long lasting comfort, with respect to contact lens wear, was assessed using the individual questionnaire item: 'I could wear these contact lenses comfortably for as long as I wanted to'. This item utilized an agreement scale of, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Long lasting comfort was assessed after 1-week of lens wear. Subjects' responses to this questionnaire item were dichotomized as Y=1 if a subject responds Strongly Agree or Agree and Y=0, otherwise. The difference in percentage of subjects that agree or strongly agree (Y=1) to the long lasting comfort was analyzed. The percentage of subjects with Y=1 in the Test lens was compared to the percentage of subjects with Y=1 in the control lens.
Time frame: 1-week Follow-up
Overall Opinion
Overall opinion, with respect to the study contact lenses, was evaluated using the individual questionnaire item 'Considering your experience with the study contact lenses, which statement best describes your overall opinion of these contact lenses?'. This item utilized an excellence scale of, 1: Poor, 2: Fair, 3: Good, 4: Very Good and 5: Excellent. Overall opinion was assessed after 1-week of lens wear. Subjects' responses to this questionnaire item were dichotomized as Y=1 if a subject responds Excellent or Very good and Y=0, otherwise. The difference in percentage of subjects that agree or strongly agree (Y=1) to the long lasting comfort was analyzed. The percentage of subjects with Y=1 in the Test lens was compared to the percentage of subjects with Y=1 in the control lens.
Time frame: 1-Week Follow-up
Comfort at the End of the Day
Comfort at the end of the day, with respect to contact lens wear, was assessed using the individual questionnaire 'These lenses were very comfortable at the end of the day'. This item utilized an agreement scale of, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Comfort at the end of the day was assessed after 1-week of lens wear. Subjects' responses to this questionnaire item were dichotomized as Y=1 if a subject responds Strongly Agree or Agree and Y=0, otherwise. The difference in percentage of subjects that agree or strongly agree (Y=1) to the long lasting comfort was analyzed. The percentage of subjects with Y=1 in the Test lens was compared to the percentage of subjects with Y=1 in the control lens.
Time frame: 1-Week Follow-up
| Milestone | Test (Senofilcon A)/Control (Delefilcon A) | Control (Delefilcon A)/Test (Senofilcon A) |
|---|---|---|
| Started | 63 | 70 |
| Completed | 63 | 70 |
| Not completed | 0 | 0 |
| Milestone | Test (Senofilcon A)/Control (Delefilcon A) | Control (Delefilcon A)/Test (Senofilcon A) |
|---|---|---|
| Started | 63 | 70 |
| Completed | 63 | 70 |
| Not completed | 0 | 0 |
Long lasting comfort, with respect to contact lens wear, was assessed using the individual questionnaire item: 'I could wear these contact lenses comfortably for as long as I wanted to'. This item utilized an agreement scale of, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Long lasting comfort was assessed after 1-week of lens wear. Subjects' responses to this questionnaire item were dichotomized as Y=1 if a subject responds Strongly Agree or Agree and Y=0, otherwise. The difference in percentage of subjects that agree or strongly agree (Y=1) to the long lasting comfort was analyzed. The percentage of subjects with Y=1 in the Test lens was compared to the percentage of subjects with Y=1 in the control lens.
| Participants | Test (Senofilcon) | Control (Delefilcon A) |
|---|---|---|
| Strongly Agree or Agree (Y=1) | 100 | 62 |
| Strongly Disagree, Disagree or Neither Agree nor Disagree (Y=0) | 33 | 71 |
Overall opinion, with respect to the study contact lenses, was evaluated using the individual questionnaire item 'Considering your experience with the study contact lenses, which statement best describes your overall opinion of these contact lenses?'. This item utilized an excellence scale of, 1: Poor, 2: Fair, 3: Good, 4: Very Good and 5: Excellent. Overall opinion was assessed after 1-week of lens wear. Subjects' responses to this questionnaire item were dichotomized as Y=1 if a subject responds Excellent or Very good and Y=0, otherwise. The difference in percentage of subjects that agree or strongly agree (Y=1) to the long lasting comfort was analyzed. The percentage of subjects with Y=1 in the Test lens was compared to the percentage of subjects with Y=1 in the control lens.
| Participants | Test (Senofilcon A) | Control (Delefilcon A) |
|---|---|---|
| Excellent or Very Good (Y=1) | 96 | 52 |
| Good, Fair or Poor (Y=0) | 37 | 81 |
Comfort at the end of the day, with respect to contact lens wear, was assessed using the individual questionnaire 'These lenses were very comfortable at the end of the day'. This item utilized an agreement scale of, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Comfort at the end of the day was assessed after 1-week of lens wear. Subjects' responses to this questionnaire item were dichotomized as Y=1 if a subject responds Strongly Agree or Agree and Y=0, otherwise. The difference in percentage of subjects that agree or strongly agree (Y=1) to the long lasting comfort was analyzed. The percentage of subjects with Y=1 in the Test lens was compared to the percentage of subjects with Y=1 in the control lens.
| Participants | Test (Senofilcon A) | Control (Delefilcon A) |
|---|---|---|
| Strongly Agree or Agree (Y=1) | 97 | 60 |
| Strongly Disagree, Disagree or Neither Agree nor Disagree (Y=0) | 36 | 73 |
Collected over Throughout the duration of the study; approximately 3 weeks per subject.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test (Senofilcon A) | 0/133 (0%) | 0/133 (0%) | 0/133 (0%) |
| Control (Delefilcon A) | 0/133 (0%) | 0/133 (0%) | 0/133 (0%) |
All subjects dispensed at least one study contact lens.
| Age, Continuous(Years) | Overall Reporting Group |
|---|---|
| Mean | 30.4 ± 5.79 |
| Sex: Female, Male(Participants) | Overall Reporting Group |
|---|---|
| Female | 88 |
| Male | 45 |
| Race (NIH/OMB)(Participants) | Overall Reporting Group |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 7 |
| White | 118 |
| More than one race | 3 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Overall Reporting Group |
|---|---|
| United States | 133 |
PDFs hosted by the registry, ClinicalTrials.gov.
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
Data sharing details ↗ · yoda.yale.edu
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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