Evaluation of Approved Contact Lenses

NCT ID: NCT07174596

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-11

Study Completion Date

2025-10-27

Brief Summary

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

Detailed Description

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Conditions

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Visual Acuity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control/Test/Test

Eligible subjects will be randomized to the control/test/test sequence, to wear the control lens, the test lens, and the test lens again for 1-week each in a daily disposable modality for at least 5 days per week and 6 hours per day.

Group Type EXPERIMENTAL

B+L Infuse spherical soft contact lenses

Intervention Type DEVICE

Test lens

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

Intervention Type DEVICE

Control lens

Test/Control/Control

Eligible subjects will be randomized to the test/control/control sequence, to wear the test lens, the control lens, and the control lens again for 1-week each in a daily disposable modality for at least 5 days per week and 6 hours per day.

Group Type EXPERIMENTAL

B+L Infuse spherical soft contact lenses

Intervention Type DEVICE

Test lens

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

Intervention Type DEVICE

Control lens

Interventions

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B+L Infuse spherical soft contact lenses

Test lens

Intervention Type DEVICE

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

Control lens

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

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.).
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Vision Care, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Vision Care, Inc.

Locations

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VisualEyes

Roswell, Georgia, United States

Site Status

New Bremen EyeCare

New Bremen, Ohio, United States

Site Status

Botetourt Eyecare LLC

Salem, Virginia, United States

Site Status

New River Vision Care

Oak Hill, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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CR-6617

Identifier Type: -

Identifier Source: org_study_id