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

NCT05258149 | Completed Results DMC FDA Device

• 1 other identifier: CR-6479
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (2)

• Clarity of Vision in Dim or Low Lighting

  Clarity of vision in dim or low lighting was assessed at the 1-week follow-up during each study period using the individual item: Clarity of vision in dim or low lighting conditions. This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary.

  1-Week Follow-up

• Clarity of Vision When Reading in Dim Light

  Clarity of vision when reading in dim light was assessed at the 1-week follow-up during each study period using the individual item: Clarity of vision when reading in dim light(e.g., menu or bill in a restaurant). This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary.

  1-Week Follow-up

Secondary Outcomes (3)

• Clarity of Distance Vision

  1-Week Follow-up

• Clarity of Intermediate Vision

  1-Week Follow-up

• Clarity of Near Vision

  1-Week Follow-up

Study Arms (2)

TEST/CONTROL/CONTROL

EXPERIMENTAL

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

Device: JJVC Investigational Multifocal Contact Lenses; Device: Dailies Total 1® Multifocal Contact Lenses

CONTROL/TEST/TEST

EXPERIMENTAL

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

Device: JJVC Investigational Multifocal Contact Lenses; Device: Dailies Total 1® Multifocal Contact Lenses

Interventions

JJVC Investigational Multifocal Contact Lenses DEVICE

TEST

CONTROL/TEST/TEST; TEST/CONTROL/CONTROL

Dailies Total 1® Multifocal Contact Lenses DEVICE

CONTROL

CONTROL/TEST/TEST; TEST/CONTROL/CONTROL

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study
• Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• Appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Be at least 40 years of age and not greater than 70 years of age at the time of consent.
• Own a wearable pair of spectacles if required for their distance vision.
• 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).
• 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).
• 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.
• The subject's refractive cylinder must be ≤0.75 D in each eye.
• The subject's ADD power must be in the range of +0.75 D to +2.50 D.
• The subject must have distance best corrected visual acuity of 20/20-3 or better in each eye.

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• The subject must not:
• Be currently pregnant or lactating.
• Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
• 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).
• 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.).
• Have a history of amblyopia, strabismus or binocular vision abnormality.
• 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.
• Use of any ocular medication, with the exception of rewetting drops.
• Have a history of herpetic keratitis.
• Have a history of irregular cornea.
• Have a history of pathological dry eye.
• Have Participated in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
• Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
• Have any known hypersensitivity or allergic reaction to non-preserved rewetting drop solutions or sodium fluorescein.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (12)

Vue Optical Boutique

Jacksonville, Florida, 32205, United States

Location

Stam & Associates Eye Care

Jacksonville, Florida, 32256, United States

Location

Sabal Eye Care

Longwood, Florida, 32779, United States

Location

Maitland Vision Center

Maitland, Florida, 32751, United States

Location

VisualEyes

Roswell, Georgia, 30076, United States

Location

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

Spectrum Eyecare

Jamestown, New York, 14750, United States

Location

Eye Associates of New York

Manhattan, New York, 10022, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

ProCare Vision Centers

Granville, Ohio, 43023, United States

Location

Tyler Eye Associates

Tyler, Texas, 75703, United States

Location

Botetourt Eyecare, LLC

Salem, Virginia, 30076, United States

Location

Results Point of Contact

• Title: Thomas R. Karkkainen, OD, MS, FAAO
• Organization: Johnson & Johnson Vision Care, Inc.

TKarkkai@its.jnj.com

1-800-843-2020

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 28, 2022
• Study Start: February 18, 2022
• Primary Completion: April 29, 2022
• Study Completion: April 29, 2022
• Last Updated: May 19, 2023
• Results First Posted: May 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (12)