Comparison of a Silicone Hydrogel Daily Disposable Multifocal Contact Lens to a Marketed Product

NCT ID: NCT05258149

Last Updated: 2023-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-18
• Study Completion Date: 2022-04-29

Brief Summary

This is a single-masked, 2×3 crossover, randomized-controlled, dispensing clinical trial to evaluate overall quality of vision.

Conditions

Visual Acuity

Study Design

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

Study Groups

TEST/CONTROL/CONTROL

Eligible subjects will be randomized into the sequence TEST/CONTROL/CONTROL.

Group Type: EXPERIMENTAL

JJVC Investigational Multifocal Contact Lenses

Intervention Type: DEVICE

TEST

Dailies Total 1® Multifocal Contact Lenses

Intervention Type: DEVICE

CONTROL

CONTROL/TEST/TEST

Eligible subjects will be randomized into the sequence CONTROL/TEST/TEST

Group Type: EXPERIMENTAL

JJVC Investigational Multifocal Contact Lenses

Intervention Type: DEVICE

TEST

Dailies Total 1® Multifocal Contact Lenses

Intervention Type: DEVICE

CONTROL

Interventions

JJVC Investigational Multifocal Contact Lenses

TEST

Intervention Type: DEVICE

Dailies Total 1® Multifocal Contact Lenses

CONTROL

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 years of age and not greater than 70 years of age at the time of consent.

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 a minimum of 2 days per week for at least 6 hours per wear day, for 1 month or more duration).

6. Either already be 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" (Appendix D).

7. The subject's distance spherical equivalent refraction (vertex corrected if ≥-4.25 D) must be in the range of -1.25 D to -5.75 D or +0.75 D to +3.25 D in each eye.

8. The subject's refractive cylinder must be ≤0.75 D in each eye.

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

10. The subject must have distance best corrected 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. Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.

3. Have any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).

4. Have any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, dacryocystorhinostomy, peripheral iridotomy/iridectomy, cataract surgery, retinal surgery, etc.).

5. Have a history of amblyopia, strabismus or binocular vision abnormality.

6. Use of any of the following medications within 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled corticosteroids. See section 9.1 for further examples.

7. Use of any ocular medication, with the exception of rewetting drops.

8. Have a history of herpetic keratitis.

9. Have a history of irregular cornea.

10. Have a history of pathological dry eye.

11. Have Participated in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

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

13. Have any known hypersensitivity or allergic reaction to non-preserved rewetting drop solutions or sodium fluorescein.

14. Have clinically significant (Grade 2 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.

15. Have any current ocular infection or inflammation.

16. Have any current ocular abnormality that may interfere with contact lens wear.

• 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

Vue Optical Boutique

Jacksonville, Florida, United States

Stam & Associates Eye Care

Jacksonville, Florida, United States

Sabal Eye Care

Longwood, Florida, United States

Maitland Vision Center

Maitland, Florida, United States

VisualEyes

Roswell, Georgia, United States

Complete Eye Care of Medina

Medina, Minnesota, United States

Spectrum Eyecare

Jamestown, New York, United States

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

Tyler Eye Associates

Tyler, Texas, 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-6479

Identifier Type: -

Identifier Source: org_study_id