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AstigmatismNCT06967129

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

A study testing 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. and 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. in people with Astigmatism, run by Johnson & Johnson Vision Care, Inc. at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for
Astigmatism
What is being tested?
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. and 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.
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
281 participants
Where
20 sitesUnited States
Study dates
25 Apr 2025to 14 Jul 2025
Phase
Interventional

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

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:
  7. Sphere powers (DS) -1.50 through -4.00 (inclusive) in 0.25 steps
  8. Cylinder powers (DC) -0.75 and -1.25
  9. Axes (°) 170, 180, 10, 80, 90, 100
  10. 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.).

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • ABQ Eye Care

    Albuquerque, New Mexico, 87109

  • Mid-State Eye

    Clinton, Illinois, 61727

  • Franklin Park Eye Center, P.C.

    Franklin Park, Illinois, 60131

  • ProCare Vision Centers

    Granville, Ohio, 43023

  • Stam & Associates Eye Care

    Jacksonville, Florida, 32256

  • Spectrum Eye Care

    Jamestown, New York, 14750

  • Pearson Research Center PA

    Longwood, Florida, 32779

  • Maitland Vision Centers - North Orlando Ave

    Maitland, Florida, 32751

  • Complete Eye Care of Medina

    Medina, Minnesota, 55340

  • Optometry Group, PLLC

    Memphis, Tennessee, 38111

  • Total Eye Care

    Memphis, Tennessee, 38119

  • James R. Dugue, Optometrist

    Mission Viejo, California, 92691

  • Kannarr Eye Care - 101 North Broadway

    Pittsburg, Kansas, 66762

  • Advanced Eyecare - Raytown, MO

    Raytown, Missouri, 64133

  • Scripps Poway Eyecare & Optometry

    San Diego, California, 92131

  • The Koetting Associates

    St Louis, Missouri, 63144

  • Tyler Eye Associates

    Tyler, Texas, 75703

  • Sacco Eye Group

    Vestal, New York, 13850

  • Professional Vision Care Inc. - Westerville

    Westerville, Ohio, 43081

  • Clarke EyeCare Center

    Wichita Falls, Texas, 76308

Other trials in United States

About this study

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
Being tested
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., 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.
Medical subject headings
Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • 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

Study groups in NCT06967129
Study groupRoleWhat they receive
Test/ControlExperimentalEligible 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.
Receives: 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/TestExperimentalEligible 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.
Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distance Monocular logMAR Visual Acuity

    Distance Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. Visual acuity is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.

    Measured: 1-Week Follow-up

  2. Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees

    Absolute rotation was assessed for each subject eye using a slit lamp 15 minutes after lens insertion. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was reported for each lens.

    Measured: 15-Minutes after Lens Insertion

  3. Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees

    Rotational Stability was assessed for each subject eye using a slit lamp 15 minutes after lens insertion. Rotational Stability was dichotomized into a binary response where Y=1 if Rotational Stability was less than or equal to 5 degrees and Y=0 otherwise (Rotational Stability greater than 5 degrees). The proportion of eyes with Rotational Stability less than or equal to 5 degrees was reported for each lens.

    Measured: 15-minutes after lens insertion

  4. Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings

    Slit Lamp Findings (SLF) were assessed using a biomicroscope and were graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported for each lens.

    Measured: Up to 1-Week Follow-up

  5. Proportion of Eyes With Acceptable Lens Fitting

    Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion at the 1-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens.

    Measured: Up to 1-Week Follow-up

Secondary outcomes (3)

  1. CLUE Vision Score

    Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

    Measured: 1-Week Follow-up

  2. CLUE Comfort Score

    Subjective comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

    Measured: 1-Week Follow-up

  3. CLUE Handling Score

    Subjective handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

    Measured: 1-Week Follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2025
  2. Study start25 Apr 2025
  3. Primary completion14 Jul 2025
  4. Study completion14 Jul 2025

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
281 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06967129
Sponsor's protocol ID
CR-6590
Status last verified
Sep 2026
First submitted
22 Apr 2025
Last updated
28 Sep 2026
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

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