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

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 Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Device: ACUVUE OASYS 1-Day for Astigmatism (AO1DfA); Device: Dailies Total 1 for Astigmatism (DT1fA)

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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:

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); Test Lens; Device: Dailies Total 1 for Astigmatism (DT1fA); Control Lens
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); Test Lens; Device: Dailies Total 1 for Astigmatism (DT1fA); Control Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Approximately 15-minutes Post Lens Insertion

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Investigators: Study Director: Johnson & Johnson Vision Care, Inc. Clinical Trial, Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2024
• Primary Completion (Actual): December 16, 2024
• Study Completion (Actual): December 16, 2024

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CR-6576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes