Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses

NCT ID: NCT06377488

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-22
• Study Completion Date: 2024-06-24

Brief Summary

This will be an open-label, 3-visit, single-arm, dispensing clinical trial to evaluate visual acuity.

Conditions

Visual Acuity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test Arm

Eligible subjects who are habitual soft contact lens wearers will be fit with the TEST lens in both eyes, to wear the lens for a minimum of 6 hours a day, every day, between visits for approximately 2 weeks.

Group Type: EXPERIMENTAL

JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filter

Intervention Type: DEVICE

Test Lens

Interventions

JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filter

Test 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 at least 40 and not more than 70 years of age at the time of screening.

4. Own a wearable pair of spectacles if required for their distance vision.

5. Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses for at least 8 hours per day at least two days per week for the past 4 weeks).

6. Be already wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".

7. The subject's distance spherical component of their refraction must be in the range of either -1.25 D to -3.75 D, or +1.25 D to +4.25 D.

8. The subject's refractive cylinder must be in the range of -1.00 D to -1.75 D in each eye, with the cylinder axes in the range of either 90°±15° or 180°±15°.

9. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.

10. The subject must have best corrected distance visual acuity of 20/20-3 or better in each eye.

Exclusion Criteria

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

The subject must not:

1. Be currently pregnant or lactating.

2. By self-report, have any systemic disease (e.g. Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, which are known to interfere with contact lens wear and/or participation in the study.

3. Use systemic medications that may interfere with contact lens wear or cause blurred vision. See Section 9.1 for additional details regarding excluded systemic medications.

4. Currently use ocular medication (with the exception of rewetting drops).

5. Have any known hypersensitivity or allergic reaction to single use preservative free rewetting drops or sodium fluorescein.

6. Have had any previous, or have any planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, cataract surgery, retinal surgery, etc.).

7. Have had previous eyelid injuries, surgeries or procedures which are known to have caused abnormal eyelid position or movement, by self-report.

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

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

10. Have a history of amblyopia or strabismus, by self-report.

11. Have a history of herpetic keratitis, by self-report.

12. Have 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, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.

13. Have any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA scale.

• Minimum Eligible Age: 40 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

Dr. James Weber & Associates, PA - City Square Blvd

Jacksonville, Florida, United States

Stam & Associates Eye Care

Jacksonville, Florida, United States

Omega Vision Center

Longwood, Florida, United States

Maitland Vision Center - North Orlando Ave

Maitland, Florida, United States

Mid-State Eye

Clinton, Illinois, United States

Kannarr Eye Care

Pittsburg, Kansas, United States

Birmingham Vision Care

Bloomfield Hills, Michigan, United States

Center for Ophthalmic and Vision Research/Eye Associates of New York

Manhattan, New York, United States

Sacco Eye Group

Vestal, New York, United States

ProCare Vision Centers

Granville, Ohio, United States

Luxe Vision and Optical

Powell, Ohio, United States

Dr. David W. Ferris & Associates

Warwick, Rhode Island, United States

Optometry Group, LLC

Memphis, Tennessee, United States

Tyler Eye Associates

Tyler, Texas, United States

New River Vision Care

Oak Hill, West Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6542

Identifier Type: -

Identifier Source: org_study_id