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OpenTrials
Completed

NCT Number: NCT07174596

Evaluation of Approved Contact Lenses

This is a prospective, randomized, controlled, subject-masked, bilateral, dispensing, multi-site, 2 lenses × 3 wearing periods crossover study to evaluate visual acuity.

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Key information

Conditions

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VisualEyes, Roswell, Georgia, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

  • Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • Be between 18 and 39 (inclusive) years of age at the time of screening. 4. By self-report, habitually wear spherical soft silicone hydrogel 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 5 days per week during the past 30 days.
  • Have a habitual contact lens prescription that is current (no power change needed) within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.
  • Possess a wearable pair of spectacles that provide correction for distance vision.
  • The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 D and -6.00 D in each eye.
  • The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye.

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

  • Be currently pregnant or lactating.
  • Be currently using any ocular medications or have any ocular infection of any type.
  • By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that the investigator believes 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.
  • Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
  • Be currently wearing monovision or multifocal contact lenses.
  • Be currently wearing lenses in an extended wear modality.
  • Have a known hypersensitivity or allergic reaction to silicone hydrogel soft contact lenses.
  • Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  • 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.
  • 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 the investigator believes might 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).
  • Have a history of strabismus or amblyopia.
  • Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
  • 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.).

Treatment and study plan

B+L Infuse spherical soft contact lenses

Device

Test lens

J&J ACUVUE OASYS 1-Day spherical soft contact lenses

Device

Control lens

Primary outcomes

  1. Proportion of Eyes Achieving 20/20 Distance Monocular Snellen VA or Better at the 1-week follow-up visit

    Time frame: At 1-week follow-up per wear period

    Visual acuity (VA) will be collected for each eye at distance using Snellen charts at the fitting evaluation and after approximately 1-week of lens wear.

  2. Proportion of Eyes with acceptable lens fit

    Time frame: Up to 3-week follow-up

    Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each eye.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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