CClinicalTrials.gg
CompletedNCT06649019Updated Feb 11, 2026Results posted

Evaluation of Lens Rotation in Habitual Wearers of Toric, Soft Contact Lenses

An interventional study of ACUVUE OASYS 1-Day for Astigmatism (AO1DfA) and Dailies Total 1 for Astigmatism (DT1fA) in Visual Acuity, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by Johnson & Johnson Vision Care, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
18 Years to 39 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Visual Acuity
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Be between 18 and 39 years of age (inclusive) at the time of screening.
  4. 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.
  5. Possess a wearable pair of spectacles that provide correction for distance vision (if applicable).
  6. Have the spherical component of their vertex-corrected distance refraction within the range +4.00 to -6.00 DS (inclusive) in both eyes.
  7. Have the magnitude of the cylindrical component of their vertex-corrected distance refraction between 0.75 DC and 2.50 DC in both eyes.
  8. Have best corrected monocular distance visual acuity of 0.2 or better in each eye.

Exclusion criteria

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Be currently pregnant or lactating.
  2. Be diabetic.
  3. Be currently using any ocular medications or have any ocular infection of any type.
  4. 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.
  5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
  6. Be currently wearing monovision or multifocal contact lenses.
  7. Be currently wearing lenses in an extended wear modality.
  8. Be currently wearing or have had worn Acuvue® Oasys 1-Day for Astigmatism, or Dailies® Total1 for Astigmatism lenses during the last 3 months.
  9. Have a history of strabismus or amblyopia.
  10. 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.
  11. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
  12. 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).
  13. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
  14. 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.).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    AO1DfA/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.

    Device: ACUVUE OASYS 1-Day for Astigmatism (AO1DfA) · Device: Dailies Total 1 for Astigmatism (DT1fA)

  • Experimental
    DT1Fa/AO1DfA

    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.

    Device: ACUVUE OASYS 1-Day for Astigmatism (AO1DfA) · Device: Dailies Total 1 for Astigmatism (DT1fA)

Interventions

  • DeviceACUVUE OASYS 1-Day for Astigmatism (AO1DfA)

    Test Lens

  • DeviceDailies Total 1 for Astigmatism (DT1fA)

    Control Lens

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Approximately 15-minutes Post Lens Insertion

07

Results

Posted Jan 7, 2026

Participant flow

A total of 6 subjects were enrolled at a single clinical site. Of those enrolled, 1 subject failed to meet all eligibility criteria and 5 subjects were dispensed both study lenses and completed the study.

Period 1
Participant flow — Period 1
MilestoneDelefilcon A/Senofilcon ASenofilcon A/Delefilcon A
Started23
Completed23
Not completed00
Period 2
Participant flow — Period 2
MilestoneDelefilcon A/Senofilcon ASenofilcon A/Delefilcon A
Started23
Completed23
Not completed00

Outcome measures

PrimaryDistance 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.

Time frame:
Approximately 15-minutes Post Lens Insertion
Reported as:
Mean · logMAR
Distance Monocular Visual Acuity (LogMAR)
logMARSenofilcon ADelefilcon A
Distance Monocular Visual Acuity (LogMAR)-0.07 ± 0.084-0.07 ± 0.050

Adverse events

Collected over Throughout the duration of the study; approximately 1-10 days per subject.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Senofilcon A0/5 (0%)0/5 (0%)0/5 (0%)
Delefilcon A0/5 (0%)0/5 (0%)0/5 (0%)

Baseline characteristics

All subjects dispensed a study lens.

Age, Continuous
Age, Continuous(Years)All Dispensed Subjects
Mean32.6 ± 5.94
Sex: Female, Male
Sex: Female, Male(Participants)All Dispensed Subjects
Female2
Male3
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Dispensed Subjects
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White5
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)All Dispensed Subjects
United Kingdom5
08

Study locations

1 site
  • The University of Manchester, Department of Optometry & Neuroscience
    Manchester, M139PL, United Kingdom
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 3, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06649019
Lead sponsor
Johnson & Johnson Vision Care, Inc.
Responsible party
Sponsor
First posted
Oct 18, 2024
Start date
Dec 6, 2024
Primary completion
Dec 16, 2024
Completion
Dec 16, 2024
Results posted
Jan 7, 2026
Last update
Feb 11, 2026

Study contacts

Johnson & Johnson Vision Care, Inc. Clinical Trial
study director · Johnson & Johnson Vision Care, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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