Visual AcuityNCT06649019
Evaluation of Lens Rotation in Habitual Wearers of Toric, Soft Contact Lenses
A study testing ACUVUE OASYS 1-Day for Astigmatism (AO1DfA) and Dailies Total 1 for Astigmatism (DT1fA) in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.
Trial summary
This will be a single site, 2-visit, randomized, controlled, single-masked, non-dispensing, bilateral wear, 2x2 cross over study to assess visual acuity. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- ACUVUE OASYS 1-Day for Astigmatism (AO1DfA) and Dailies Total 1 for Astigmatism (DT1fA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Dec 2024to 16 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Be between 18 and 39 years of age (inclusive) at the time of screening.
- Habitually wear soft, toric contact lenses in both eyes in a daily or daily disposable wear modality (i.e. not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past 30 days.
- Possess a wearable pair of spectacles that provide correction for distance vision (if applicable).
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- Have the spherical component of their vertex-corrected distance refraction within the range +4.00 to -6.00 DS (inclusive) in both eyes.
- Have the magnitude of the cylindrical component of their vertex-corrected distance refraction between 0.75 DC and 2.50 DC in both eyes.
- Have best corrected monocular distance visual acuity of 0.2 or better in each eye.
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Be currently pregnant or lactating.
- Be diabetic.
- Be currently using any ocular medications or have any ocular infection of any type.
- By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.
- Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
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- Be currently wearing monovision or multifocal contact lenses.
- Be currently wearing lenses in an extended wear modality.
- Be currently wearing or have had worn Acuvue® Oasys 1-Day for Astigmatism, or Dailies® Total1 for Astigmatism lenses during the last 3 months.
- Have a history of strabismus or amblyopia.
- Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
- Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- Have clinically significant (grade 3 or higher on the Efron grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
- Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
- Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The University of Manchester, Department of Optometry & Neuroscience
Manchester, M139PL
About this study
This will be a single site, 2-visit, randomized, controlled, single-masked, non-dispensing, bilateral wear, 2x2 cross over study to assess visual acuity.
- Conditions
- Visual Acuity
- Being tested
- ACUVUE OASYS 1-Day for Astigmatism (AO1DfA), Dailies Total 1 for Astigmatism (DT1fA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACUVUE OASYS 1-Day for Astigmatism (AO1DfA)Device
Test Lens
Dailies Total 1 for Astigmatism (DT1fA)Device
Control Lens
| Study group | Role | What they receive |
|---|---|---|
| AO1DfA/DT1fA | Experimental | Eligible subjects will be randomized into the AO1DfA/DT1fA wear sequence, to wear the test lens followed by the control lens, bilaterally, with a 1-to-10 day(s) washout period between wear periods. Receives: Device: ACUVUE OASYS 1-Day for Astigmatism (AO1DfA); Device: Dailies Total 1 for Astigmatism (DT1fA) |
| DT1Fa/AO1DfA | Experimental | Eligible subjects will be randomized into the DT1Fa/AO1DfA wear sequence, to wear the control lens followed by the test lens, bilaterally, with a 1-to-10 day(s) washout period between wear periods. Receives: Device: ACUVUE OASYS 1-Day for Astigmatism (AO1DfA); Device: Dailies Total 1 for Astigmatism (DT1fA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Monocular Visual Acuity (LogMAR)
Distance visual acuity was measured monocularly at 6 meters after lens fitting under high-luminance high contrast (HLHC) lighting conditions using the Eurolens computerized logMAR VA chart. Lower scores indicate better visual acuity. A value of 0.0 logMAR is equivalent to 20/20 vision on a Snellen visual acuity chart.
Measured: Approximately 15-minutes Post Lens Insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start6 Dec 2024
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Visual AcuityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Vision Care, Inc. Clinical Trial, Study director, Johnson & Johnson Vision Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649019
- Sponsor's protocol ID
- CR-6576
- Status last verified
- Jan 2026
- First submitted
- 16 Oct 2024
- Last updated
- 11 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lens Rotation in Habitual Wearers of Toric, Soft Contact Lenses
- ClinicalTrials.gov ID
- NCT06649019
- Acronym / sponsor ID
- CR-6576
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 18 Oct 2024 (actual)
- Results
- Posted 7 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a single site, 2-visit, randomized, controlled, single-masked, non-dispensing, bilateral wear, 2x2 cross over study to assess visual acuity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AO1DfA/DT1fA | Experimental | Device: ACUVUE OASYS 1-Day for Astigmatism (AO1DfA), Device: Dailies Total 1 for Astigmatism (DT1fA)Eligible subjects will be randomized into the AO1DfA/DT1fA wear sequence, to wear the test lens followed by the control lens, bilaterally, with a 1-to-10 day(s) washout period between wear periods. |
| DT1Fa/AO1DfA | Experimental | Device: ACUVUE OASYS 1-Day for Astigmatism (AO1DfA), Device: Dailies Total 1 for Astigmatism (DT1fA)Eligible subjects will be randomized into the DT1Fa/AO1DfA wear sequence, to wear the control lens followed by the test lens, bilaterally, with a 1-to-10 day(s) washout period between wear periods. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Be between 18 and 39 years of age (inclusive) at the time of screening.
- Habitually wear soft, toric contact lenses in both eyes in a daily or daily disposable wear modality (i.e. not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past 30 days.
Key exclusion criteria (15 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Be currently pregnant or lactating.
- Be diabetic.
- Be currently using any ocular medications or have any ocular infection of any type.
- By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACUVUE OASYS 1-Day for Astigmatism (AO1DfA)Test Lens | Device | AO1DfA/DT1fA, DT1Fa/AO1DfA |
| Dailies Total 1 for Astigmatism (DT1fA)Control Lens | Device | AO1DfA/DT1fA, DT1Fa/AO1DfA |
Primary outcome
Distance Monocular Visual Acuity (LogMAR)
Time frame: Approximately 15-minutes Post Lens Insertion
Distance visual acuity was measured monocularly at 6 meters after lens fitting under high-luminance high contrast (HLHC) lighting conditions using the Eurolens computerized logMAR VA chart. Lower scores indicate better visual acuity. A value of 0.0 logMAR is equivalent to 20/20 vision on a Snellen visual acuity chart.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Vision Care, Inc. Clinical Trial study director
Johnson & Johnson Vision Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACUVUE OASYS 1-Day for Astigmatism (AO1DfA) and Dailies Total 1 for Astigmatism (DT1fA) in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance Monocular Visual Acuity (LogMAR) (time frame: Approximately 15-minutes Post Lens Insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.