An interventional study of INFUSE® One Day Multifocal and ACUVUE® OASYS MAX 1-Day Multifocal Contact Lens in Visual Acuity and Presbyopia, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 7 sites in United States. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Johnson & Johnson Vision Care, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment
This is a 6-visit, single-masked, multi-site, 2×3 crossover, randomized-controlled, dispensing clinical trial to evaluate visual acuity.
336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.
This study's enrollment of 74 is above the median of 61 across 276 interventional studies indexed under Presbyopia.
Browse Presbyopia 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:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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 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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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/Control sequence.
Device: INFUSE® One Day Multifocal · Device: ACUVUE® OASYS MAX 1-Day Multifocal Contact Lens
Eligible subjects will be randomized into the Control/Test/Test sequence.
Device: INFUSE® One Day Multifocal · Device: ACUVUE® OASYS MAX 1-Day Multifocal Contact Lens
Test Lens
Control Lens
High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuity at Distance (4m)
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. 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: 1-Week Follow-up
High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuity at Intermediate (64cm)
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. 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: 1-Week Follow-up
High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuity at Near (40cm)
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. 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: 1-Week Follow-up
| Milestone | Kalifilcon A/ Senofilcon A C3/ Senofilcon A C3 | Senofilcon A C3/ Kalifilcon A/ Kalifilcon A |
|---|---|---|
| Started | 36 | 34 |
| Completed | 36 | 34 |
| Not completed | 0 | 0 |
| Milestone | Kalifilcon A/ Senofilcon A C3/ Senofilcon A C3 | Senofilcon A C3/ Kalifilcon A/ Kalifilcon A |
|---|---|---|
| Started | 36 | 34 |
| Completed | 36 | 33 |
| Not completed | 0 | 1 |
| Withdrew: Unsatisfactory lens fitting due to test article | 0 | 1 |
| Milestone | Kalifilcon A/ Senofilcon A C3/ Senofilcon A C3 | Senofilcon A C3/ Kalifilcon A/ Kalifilcon A |
|---|---|---|
| Started | 36 | 33 |
| Completed | 36 | 33 |
| Not completed | 0 | 0 |
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. 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 | Kalifilcon A | Senofilcon A C3 |
|---|---|---|
| High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuity at Distance (4m) | -0.058 ± 0.1013 | -0.071 ± 0.1002 |
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. 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 | Kalifilcon A | Senofilcon A C3 |
|---|---|---|
| High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuity at Intermediate (64cm) | -0.045 ± 0.0968 | -0.049 ± 0.0912 |
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. 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 | Kalifilcon A | Senofilcon A C3 |
|---|---|---|
| High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuity at Near (40cm) | 0.076 ± 0.0999 | 0.069 ± 0.0980 |
Collected over Throughout the duration of the study, adverse events were monitored for approximately 32 days per subject.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Kalifilcon A | 0/70 (0%) | 0/70 (0%) | 0/70 (0%) |
| Senofilcon A C3 | 0/70 (0%) | 0/70 (0%) | 0/70 (0%) |
All subjects dispensed a study lens.
| Age, Continuous(Years) | Kalifilcon A/ Senofilcon A C3/ Senofilcon A C3 | Senofilcon A C3/ Kalifilcon A/ Kalifilcon A | Total |
|---|---|---|---|
| Mean | 55.8 ± 7.56 | 55.7 ± 7.38 | 55.7 ± 7.42 |
| Sex: Female, Male(Participants) | Kalifilcon A/ Senofilcon A C3/ Senofilcon A C3 | Senofilcon A C3/ Kalifilcon A/ Kalifilcon A | Total |
|---|---|---|---|
| Female | 29 | 28 | 57 |
| Male | 7 | 6 | 13 |
| Race (NIH/OMB)(Participants) | Kalifilcon A/ Senofilcon A C3/ Senofilcon A C3 | Senofilcon A C3/ Kalifilcon A/ Kalifilcon A | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 8 | 14 |
| White | 30 | 26 | 56 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Kalifilcon A/ Senofilcon A C3/ Senofilcon A C3 | Senofilcon A C3/ Kalifilcon A/ Kalifilcon A | Total |
|---|---|---|---|
| United States | 36 | 34 | 70 |
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 Oct 2026. You cannot join it, but the record below documents what was studied.
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