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

NCT05101252 | Completed Results FDA Device

• 1 other identifier: CR-6468
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 9

Brief Summary

This is a single-masked, two-arm, parallel-group, randomized-controlled, dispensing clinical trial to evaluate the visual performance.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (2)

• Binocular logMAR Visual Acuity

  Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.

  1-Week Follow-up

• CLUE Vision Score

  Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patientreported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE vision score for each lens type was reported.

  1-Week Follow-up

Secondary Outcomes (1)

• Binocular Distance logMAR Visual Acuity

  1-Week Follow-up

Study Arms (2)

TEST Lens

ACTIVE COMPARATOR

Eligible subjects who are habitual soft contact lens wearers will be randomized to the TEST Lens sequence for the duration of the study.

Device: senofilcon A C3

CONTROL Lens

EXPERIMENTAL

Eligible subjects who are habitual soft contact lens wearers will be randomized to the CONTROL Lens sequence for the duration of the study.

Device: Dailies Total 1 Multifocal Contact Lenses

Interventions

senofilcon A C3 DEVICE

TEST Lens

TEST Lens

Dailies Total 1 Multifocal Contact Lenses DEVICE

CONTROL Lens

CONTROL Lens

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 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".
• The subject's distance spherical equivalent refraction must be in the range of -1.25 D to -3.75 D or +1.25 D to +3.75 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:
• 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, 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 Table 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 and 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.
• Have clinically significant (Grade 3 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (9)

Stam & Associates Eye Care

Jacksonville, Florida, 32256, United States

Location

Sabal Eye Care

Longwood, Florida, 32779, United States

Location

Visual Eyes

Roswell, Georgia, 30076, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Birmingham Vision Care

Bloomfield Township, Michigan, 48301, United States

Location

Eye Associates of New York

New York, New York, 10022, United States

Location

ProCare Vision Centers

Granville, Ohio, 43023, United States

Location

West Bay Eye Associates

Warwick, Rhode Island, 028888, United States

Location

Tyler Eye Associates

Tyler, Texas, 75703, United States

Location

Results Point of Contact

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

TKarkkai@its.jnj.com

(904)254-0152

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: November 1, 2021
• Study Start: October 11, 2021
• Primary Completion: November 29, 2021
• Study Completion: November 29, 2021
• Last Updated: January 10, 2023
• Results First Posted: January 10, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share

Locations

US (9)