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Evaluation of new daily disposable toric soft contact lenses for astigmatism

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

Not applicable Interventional Johnson & Johnson Vision Care, Inc. · NCT06967129

This study tests a new daily disposable contact lens for people with astigmatism to see if it provides better comfort and vision correction than a standard lens.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment282 (estimated)
Ages18 Years to 39 Years
SexAll
SponsorJohnson & Johnson Vision Care, Inc. Industry-sponsored
Locations20 sites (Mission Viejo, California and 19 other locations)
Trial IDNCT06967129 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to evaluate the safety and effectiveness of a new type of daily disposable toric soft contact lens manufactured using an innovative hydration process. The study employs a randomized, controlled, double-masked, bilateral wear, 2x2 crossover design, allowing participants to wear both the investigational lenses and a control lens. Participants will be monitored for their comfort and vision correction capabilities over the course of the trial. The goal is to determine if the new lens technology offers improved performance for individuals with astigmatism.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 39 who habitually wear soft contact lenses and have specific astigmatic refractive errors.

Not a fit: Patients who do not wear soft contact lenses or have refractive errors outside the specified range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with a more comfortable and effective option for correcting astigmatism.

How similar studies have performed: Previous studies have shown promise in the development of advanced contact lens technologies, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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 (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.).

Where this trial is running

Mission Viejo, California and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Astigmatism
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.