Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population

NCT03581825 | Completed Results FDA Device

• 1 other identifier: CR-6201
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 6

Brief Summary

This is a single-masked, randomized-controlled, dispensing clinical trial. A total of approximately 60 eligible myopic subjects will be targeted to complete the study.

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)

• CLUE Vision Comparison Between Test and Control

  2-Week Follow-up

Study Arms (2)

Test/Control

EXPERIMENTAL

Myopic subjects who are habitual soft contact lens wearers between the ages of 40 and 70 years of age, will be randomized to sequence Test/Control. Alternative Spherical lenses will be used if optimization cannot be achieved with the Multifocal lenses.

Device: senofilcon A Multifocal; Device: senofilcon A Sphere; Device: etafilcon A Multifocal; Device: etafilcon A Sphere

Control/Test

EXPERIMENTAL

Myopic subjects who are habitual soft contact lens wearers between the ages of 40 and 70 years of age, will be randomized to sequence Control/Test. Alternative Spherical lenses will be used if optimization cannot be achieved with the Multifocal lenses.

Device: senofilcon A Multifocal; Device: senofilcon A Sphere; Device: etafilcon A Multifocal; Device: etafilcon A Sphere

Interventions

senofilcon A Multifocal DEVICE

JJVC Investigational Multifocal Contact Lens

Control/Test; Test/Control

senofilcon A Sphere DEVICE

ACUVUE OASYS 2-WEEK with HYDRACLEAR PLUS

Control/Test; Test/Control

etafilcon A Multifocal DEVICE

1-Day Acuvue Moist Brand Multifocal Contact Lens

Control/Test; Test/Control

etafilcon A Sphere DEVICE

1-Day Acuvue Moist Brand Contact Lens

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 between 40 and 70 years of age (inclusive).
• 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, 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, oral antihistamines (e.g., Chlor-Trimeton, and Benadryl), 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 (6)

Coughlin Eye Center

Orlando, Florida, 32819, United States

Location

VisionCare Associates

East Lansing, Michigan, 48823, United States

Location

Eyecare Management Company, LLC

Raytown, Missouri, 64133, United States

Location

Jamestown Optometric Group

Jamestown, New York, 14701, United States

Location

Susquehanna Eye Care

Vestal, New York, 13850, United States

Location

Bryan Frazier, OD

Tyler, Texas, 75703, 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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 10, 2018
• Study Start: June 8, 2018
• Primary Completion: August 20, 2018
• Study Completion: August 20, 2018
• Last Updated: May 8, 2020
• Results First Posted: April 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share

Locations

US (6)