Clinical Evaluation of Manufacturing Processes for a Reusable Multifocal Optical Design in a Presbyopic Population

NCT03787472 | Completed Results FDA Device

• 1 other identifier: CR-6317
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 5

Brief Summary

The clinical study is a randomized-controlled, double-masked, crossover clinical trial with two study treatments to compare two study lens types and the initial performance, in terms of the subjective response after a period of lens dispensing. The study will last approximately 2 to 4 months.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• CLUE Vision

  Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported 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.

  2-Week Follow-up

Secondary Outcomes (1)

• logMAR Visual Acuity

  2-Week Follow-up

Study Arms (2)

Test/Control

EXPERIMENTAL

Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized into one the sequence (Test/Control).

Device: JJV Investigational senofilcon A Multifocal Lens1; Device: JJV Investigational senofilcon A Multifocal Lens2

Control/Test

EXPERIMENTAL

Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized into the sequence (Control/Test).

Device: JJV Investigational senofilcon A Multifocal Lens1; Device: JJV Investigational senofilcon A Multifocal Lens2

Interventions

JJV Investigational senofilcon A Multifocal Lens1 DEVICE

CONTROL

Control/Test; Test/Control

JJV Investigational senofilcon A Multifocal Lens2 DEVICE

TEST

Control/Test; Test/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 the following criteria to be enrolled in the study:
• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
• The subject must be at least 40 years of age and not greater than 70 years of age.
• The subject's distance spherical equivalent refraction must be in the range of +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.
• Subjects must own a wearable pair of spectacles if required for their distance vision.
• The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration).
• The subject must 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".

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Currently pregnant or lactating.
• Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
• 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).
• Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
• Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
• Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, dacryocystorhinostomy cataract surgery, retinal surgery, etc.).
• A history of amblyopia, strabismus or binocular vision abnormality.
• Any current ocular infection or inflammation.
• Any current ocular abnormality that may interfere with contact lens wear.
• Use of any of the following oral medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, systemic steroids.
• Use of any ocular medication, with the exception of rewetting drops.
• History of herpetic keratitis.
• Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
• Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (5)

Maitland Vision Center

Maitland, Florida, 32751, United States

Location

Advanced Eyecare

Raytown, Missouri, 64133, United States

Location

Spectrum Eyecare

Jamestown, New York, 14701, United States

Location

Western Reserve Vision Care, Inc

Beachwood, Ohio, 44122, United States

Location

ProCare Vision Centers

Granville, Ohio, 43023, United States

Location

Results Point of Contact

• Title: Thomas R. Karkkainen, OD, MS, FAAO- Sr. Principal Research Optometrist
• Organization: Johnson & Johnson Vision Care

TKarkkai@its.jnj.com

904-443-3402

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: December 26, 2018
• Study Start: January 11, 2019
• Primary Completion: March 22, 2019
• Study Completion: March 22, 2019
• Last Updated: June 23, 2020
• Results First Posted: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share

Locations

US (5)