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Evaluation of Approved Contact Lenses

Evaluation of Approved Contact Lenses

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07174596
Enrollment
85
Registered
2025-09-16
Start date
2025-09-11
Completion date
2025-10-27
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Acuity

Brief summary

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

Interventions

DEVICEB+L Infuse spherical soft contact lenses

Test lens

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

Control lens

Sponsors

Johnson & Johnson Vision Care, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes

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 (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. 5\. 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. 6\. Possess a wearable pair of spectacles that provide correction for distance vision. 7\. The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 D and -6.00 D in each eye. 8\. 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: 1. Be currently pregnant or lactating. 2. Be currently using any ocular medications or have any ocular infection of any type. 3. 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. 4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months. 5. Be currently wearing monovision or multifocal contact lenses. 6. Be currently wearing lenses in an extended wear modality. 7. Have a known hypersensitivity or allergic reaction to silicone hydrogel soft contact lenses. 8. Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment. 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 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). 11. Have a history of strabismus or amblyopia. 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, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Eyes Achieving 20/20 Distance Monocular Snellen VA or Better at the 1-week follow-up visitAt 1-week follow-up per wear periodVisual 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.
Proportion of Eyes with acceptable lens fitUp to 3-week follow-upAcceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each eye.

Countries

United States

Contacts

STUDY_DIRECTORJohnson & Johnson Vision Care, Inc. Clinical Trial

Johnson & Johnson Vision Care, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026