Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology

NCT ID: NCT04531241

Last Updated: 2021-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-05
• Study Completion Date: 2020-09-25

Brief Summary

This study is a multi-site, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.

Conditions

Visual Acuity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test/Control

Eligible subjects that are habitual wearers of daily disposable contact lenses in both eyes will be randomly assigned to sequence, Test/Control.

Group Type: EXPERIMENTAL

ACUVUE® OASYS 1-DAY

Intervention Type: DEVICE

senofilcon A contact lenses made with a novel manufacturing technology

ACUVUE® OASYS 1-DAY

Intervention Type: DEVICE

senofilcon A contact lenses made with the current manufacturing technology

Control/Test

Eligible subjects that are habitual wearers of daily disposable contact lenses in both eyes will be randomly assigned to sequence, Control/Test.

Group Type: EXPERIMENTAL

ACUVUE® OASYS 1-DAY

Intervention Type: DEVICE

senofilcon A contact lenses made with a novel manufacturing technology

ACUVUE® OASYS 1-DAY

Intervention Type: DEVICE

senofilcon A contact lenses made with the current manufacturing technology

Interventions

ACUVUE® OASYS 1-DAY

senofilcon A contact lenses made with a novel manufacturing technology

Intervention Type: DEVICE

ACUVUE® OASYS 1-DAY

senofilcon A contact lenses made with the current manufacturing technology

Intervention Type: DEVICE

Other Intervention Names

TEST; CONTROL

Eligibility Criteria

Inclusion Criteria

1. The subject must 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. Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.

4. The subject must be a habitual and adapted wearer of daily disposable contact lenses in both eyes (at least 1 month of daily wear).

5. The subject must have normal eyes (i.e., no ocular medications or infections of any type).

6. The subject's required spherical contact lens prescription must be in the range of -0.50 to -3.25 and -3.75 to -6.00 D in each eye.

7. The subject's refractive cylinder must be ≤0.75D in each eye, if present

8. The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).

2. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear. (at the discretion of the investigator)

3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).

4. Any ocular infection.

5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

6. Monovision or multi-focal contact lens correction.

7. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

8. History of binocular vision abnormality or strabismus.

9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).

10. Suspicion of or recent history of alcohol or substance abuse.

11. History of serious mental illness.

12. History of seizures.

13. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)

14. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion

15. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Food and Drug Administration (FDA) classification scale.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Vision Care, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Vision Care, Inc.

Locations

Vue Optical Boutique

Jacksonville, Florida, United States

Maitland Vision Center

Maitland, Florida, United States

Tallahassee Eye Center

Tallahassee, Florida, United States

VisionPoint Eye Center

Bloomington, Illinois, United States

ProCare Vision Centers

Granville, Ohio, United States

EyeCare Professionals of Powell

Powell, Ohio, United States

Frazier Vision, Inc.

Tyler, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6417

Identifier Type: -

Identifier Source: org_study_id