Evaluation of Two Marketed Multifocal Contact Lenses

NCT03322423 | Completed Results FDA Device

• 1 other identifier: CR-5860
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 5

Brief Summary

This is a single-masked, randomized, cross-over, dispensing, 6- visit pilot study. The purpose of this clinical study is to evaluate the performance of two marketed multifocal lenses.

Conditions

Visual Performance

Outcome Measures

Primary Outcomes (2)

• Distance Binocular Visual Acuity

  Distance visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts.

  1-Week Follow-up

• Near Binocular Visual Acuity

  Near visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using reduced Guillon-Poling Charts.

  1-Week Follow-up

Secondary Outcomes (1)

• Overall Quality of Vision

  1-Week Follow-up

Study Arms (2)

Test 1 Multifocal/Test 2 Multifocal OR Test 2 Alternative

ACTIVE COMPARATOR

Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 1 Multifocal then Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power), for approximately 8-12 days of wear with an approximately 4-8 day washout period.

Device: Multifocal Contact Lens 1; Device: Multifocal Contact Lens 2; Device: Spherical Contact Lens 2

Test 2 Multifocal OR Test 2 Alternative/Test 1 Multifocal

ACTIVE COMPARATOR

Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power) then Test 1 Multifocal, for approximately 8-12 days of wear with an approximately 4-8 day washout period.

Device: Multifocal Contact Lens 1; Device: Multifocal Contact Lens 2; Device: Spherical Contact Lens 2

Interventions

Multifocal Contact Lens 1 DEVICE

Dailies Total 1 Multifocal Contact Lens

Also known as: Test 1 Multifocal , delefilcon A

Test 1 Multifocal/Test 2 Multifocal OR Test 2 Alternative; Test 2 Multifocal OR Test 2 Alternative/Test 1 Multifocal

Multifocal Contact Lens 2 DEVICE

Biotrue ONEday for Presbyopia Contact Lenses

Also known as: Test 2 Multifocal, nesofilcon A

Test 1 Multifocal/Test 2 Multifocal OR Test 2 Alternative; Test 2 Multifocal OR Test 2 Alternative/Test 1 Multifocal

Spherical Contact Lens 2 DEVICE

BioTrue ONEDay Spherical

Also known as: Test 2 Alternative, nesofilcon A

Test 1 Multifocal/Test 2 Multifocal OR Test 2 Alternative; Test 2 Multifocal OR Test 2 Alternative/Test 1 Multifocal

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:
• 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 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 +3.75 D to -3.75 D.
• 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 in each eye.
• The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
• The subject must own a pair of wearable 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 or more duration).
• The subject must either be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or 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:
• Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.
• Pregnancy or lactation.
• Currently diagnosed with diabetes.
• Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).
• 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 ocular infection or inflammation.
• Any ocular abnormality that may interfere with contact lens wear.
• 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 of clinical site (e.g., Investigator, Coordinator, Technician)

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (5)

Golden Vision

Sarasota, Florida, 34232, United States

Location

ABQ Eye Care

Albuquerque, New Mexico, 87109, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

West Bay Eye Associates

Warwick, Rhode Island, 02888, United States

Location

Botetourt Eyecare, LLC

Salem, Virginia, 24153, United States

Location

Results Point of Contact

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

TKarkkai@its.jnj.com

1-904-443-3402

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: September 28, 2017
• First Posted: October 26, 2017
• Study Start: September 11, 2017
• Primary Completion: November 4, 2017
• Study Completion: November 4, 2017
• Last Updated: January 8, 2019
• Results First Posted: January 8, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)