Validation of Senofilcon A With New UV / HEV Filter

NCT ID: NCT05099380

Last Updated: 2023-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 296 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-05
• Study Completion Date: 2021-11-24

Brief Summary

This is a bilateral, dispensing, randomized, controlled, subject-masked, 2-arm parallel study to evaluate safety and efficacy

Conditions

Visual Acuity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TEST lens

Eligible subjects that are habitual wearers of silicone hydrogel spherical contact lenses will be randomized to the TEST Lens for the duration of the study.

Group Type: EXPERIMENTAL

senofilcon A C3

Intervention Type: DEVICE

TEST Lens

CONTROL lens

Eligible subjects that are habitual wearers of silicone hydrogel spherical contact lenses will be randomized to the CONTROL Lens for the duration of the study.

Group Type: ACTIVE_COMPARATOR

senofilcon A

Intervention Type: DEVICE

CONTROL Lens

Interventions

senofilcon A C3

TEST Lens

Intervention Type: DEVICE

senofilcon A

CONTROL Lens

Intervention Type: DEVICE

Eligibility Criteria

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 silicone hydrogel 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 5 days per week during the past 30 days.

5. Have a habitual contact lens prescription that is current within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.

6. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D in both eyes.

7. The subject's refractive cylinder must be 1.00 D or less.

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

Exclusion Criteria

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

1. Be currently pregnant or lactating.

2. Have any ocular or systemic allergies or diseases that may interfere with contact lens wear.

3. Have any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.

4. Have any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).

5. Be currently wearing lenses in a monovision, multifocal, toric, or extended wear modality.

6. Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment

7. 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.

8. Have a history of binocular vision abnormality or strabismus.

9. Have any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report. 10. Have any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.

11. Have any ocular infection. 12. Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

13. Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 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

James T. Fujimoto, O.D.

Cupertino, California, United States

Randall Go, OD

San Francisco, California, United States

Dr. James Weber & Associates, PA

Jacksonville, Florida, United States

Sabal Eye Care

Longwood, Florida, United States

Flora Chen Poveda, OD, PA

Orange Park, Florida, United States

Tallahassee Eye Center

Tallahassee, Florida, United States

VisualEyes, Inc

Roswell, Georgia, United States

Kannarr Eye Care

Pittsburg, Kansas, United States

Birmingham Vision Care

Bloomfield Township, Michigan, United States

Dr. Debbie H. Kim, OD

Closter, New Jersey, United States

Sacco Eye Group

Vestal, New York, United States

Professional Vision Care, Inc.

Westerville, Ohio, United States

West Bay Eye Associates

Warwick, Rhode Island, United States

Primary Eyecare Group

Brentwood, Tennessee, United States

Tyler Eye Associates

Tyler, Texas, United States

William J. Bogus, OD, FAAO

Salt Lake City, Utah, United States

Botetourt Eyecare, LLC

Salem, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6470

Identifier Type: -

Identifier Source: org_study_id