Evaluation of Daily Disposable Toric Soft Lenses Manufactured With an Alternative Hydration Process

NCT06967129 | Completed FDA Device

• 1 other identifier: CR-6590
• Study Type: interventional
• Target: 281
• Locations: 1 country
• Sites: 20

Brief Summary

This is a prospective, multi-site, dispensing, randomized, controlled, double-masked, bilateral wear, 2x2 crossover study to evaluate the safety and effectiveness of the test lens.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (5)

• Distance (4m) Monocular High Luminance High Contrast (HLHC) logMAR Visual Acuity (VA)

  VA will be assessed monocularly under HLHC conditions at a test distance of 4 meters using ETDRS Charts.

  At each 1-week follow-up per wear period

• Toric Lens Orientation

  Toric lens orientation (scribe mark position relative to 6 o'clock) will be assessed for each eye at 15 minutes after lens insertion. Toric lens orientation will be used to define a binary endpoint, i.e. the percentage of eyes that achieve absolute toric lens rotation ≤ 10°.

  At baseline per wear period

• Lens Rotational Stability with Blinks

  Rotational stability will be assessed for each eye at least 15 minutes after lens insertion. Lens rotational stability with blinks will be defined as a binary endpoint, the percentage of eyes that achieve rotational stability with blinks ≤ 5°.

  At baseline per wear period

• Percentage of eyes with Grade 3 or higher SLFs relating to the test lens

  SLFs (Grade 3 or higher) related to study lens wear for the test lens will be assessed for each eye at all study visits (scheduled and unscheduled). SLFs will be evaluated and graded using the FDA Grading scale from 0 to 4, where Grade 0 represents the absence of findings and 1 to 4 representing successively worse findings. The percentage of eyes with Grade 3 or higher SLF will be analyzed and will include corneal infiltrates.

  Up to 3-week follow-up

• Percentage of eyes with acceptable lens fitting while wearing the test lens

  Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each subject eye and used to define a binary endpoint, i.e. the percentage of eyes that achieve acceptable lens fit while wearing the test lens. Lens fit will be deemed unacceptable if any one of the following criteria are met: * limbal exposure at primary gaze or with extreme eye movement. * edge lift. * excessive movement on blink in primary gaze. * insufficient movement in all three of the following conditions: primary gaze, up gaze, and push up test.

  Up to 3-week follow-up

Secondary Outcomes (3)

• Subjective Overall Comfort

  At each 1-week follow-up per wear period

• Subjective Overall Quality of Vision

  At each 1-week follow-up per wear period

• Subjective Overall Handling

  At each 1-week follow-up per wear period

Study Arms (2)

Test/Control

EXPERIMENTAL

Eligible subjects will be randomized to the Test/Control sequence, to wear the Test Lens followed by the Control Lens bilaterally for approximately 1-week each in a daily disposable modality with a washout period of approximately 1-week between wear periods.

Device: Investigational daily disposable, soft, toric lenses manufactured on 4th Generation Technology (4GT) lines with extended mini-stack hydration using propylene glycol (PG) as the hydration solvent.; Device: ACUVUE® Oasys 1-Day for Astigmatism (AO1DfA) soft contact lenses manufactured on 3rd Generation Technology (3GT) legacy lines using isopropyl alcohol (IPA) as the hydration solvent.

Control/Test

EXPERIMENTAL

Eligible subjects will be randomized to the Control/Test sequence, to wear the Control Lens followed by the Test Lens bilaterally for approximately 1-week each in a daily disposable modality with a washout period of approximately 1-week between wear periods.

Device: Investigational daily disposable, soft, toric lenses manufactured on 4th Generation Technology (4GT) lines with extended mini-stack hydration using propylene glycol (PG) as the hydration solvent.; Device: ACUVUE® Oasys 1-Day for Astigmatism (AO1DfA) soft contact lenses manufactured on 3rd Generation Technology (3GT) legacy lines using isopropyl alcohol (IPA) as the hydration solvent.

Interventions

Investigational daily disposable, soft, toric lenses manufactured on 4th Generation Technology (4GT) lines with extended mini-stack hydration using propylene glycol (PG) as the hydration solvent. DEVICE

Test Lens

Control/Test; Test/Control

ACUVUE® Oasys 1-Day for Astigmatism (AO1DfA) soft contact lenses manufactured on 3rd Generation Technology (3GT) legacy lines using isopropyl alcohol (IPA) as the hydration solvent. DEVICE

Control Lens

Control/Test; Test/Control

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 (inclusive) years of age at the time of screening. 4. By self-report, habitually wear soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 2 days per week during last 30 days. 5. Possess a wearable pair of spectacles that provide correction for distance vision. 6. In both eyes, have astigmatic refractive error suitable for correction with the toric contact lens powers available in this study: 1. Sphere powers (DS) -1.50 through -4.00 (inclusive) in 0.25 steps 2. Cylinder powers (DC) -0.75 and -1.25 3. Axes (°) 170, 180, 10, 80, 90, 100 7. Have best corrected monocular distance visual acuity of 20/30 or better in each eye. 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 an 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. Have a history of strabismus or amblyopia. 9. 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. 10. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment. 11. Have clinically significant (grade 3 or higher on the FDA 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). 12. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions. 13. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, Photorefractive Keratectomy \[PRK\], Laser-Assisted in Situ Keratomileusis \[LASIK\], iridotomy, retinal laser photocoagulation, etc.).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (20)

James R. Dugue, Optometrist

Mission Viejo, California, 92691, United States

Location

Scripps Poway Eyecare & Optometry

San Diego, California, 92131, United States

Location

Stam & Associates Eye Care

Jacksonville, Florida, 32256, United States

Location

Pearson Research Center PA

Longwood, Florida, 32779, United States

Location

Maitland Vision Centers - North Orlando Ave

Maitland, Florida, 32751, United States

Location

Mid-State Eye

Clinton, Illinois, 61727, United States

Location

Franklin Park Eye Center, P.C.

Franklin Park, Illinois, 60131, United States

Location

Kannarr Eye Care - 101 North Broadway

Pittsburg, Kansas, 66762, United States

Location

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

Advanced Eyecare - Raytown, MO

Raytown, Missouri, 64133, United States

Location

The Koetting Associates

St Louis, Missouri, 63144, United States

Location

ABQ Eye Care

Albuquerque, New Mexico, 87109, United States

Location

Spectrum Eye Care

Jamestown, New York, 14750, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

ProCare Vision Centers

Granville, Ohio, 43023, United States

Location

Professional Vision Care Inc. - Westerville

Westerville, Ohio, 43081, United States

Location

Optometry Group, PLLC

Memphis, Tennessee, 38111, United States

Location

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

Tyler Eye Associates

Tyler, Texas, 75703, United States

Location

Clarke EyeCare Center

Wichita Falls, Texas, 76308, United States

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 13, 2025
• Study Start: April 25, 2025
• Primary Completion: July 14, 2025
• Study Completion: July 14, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (20)