Evaluation of Two Marketed Multifocal Contact Lenses

Johnson & Johnson Vision Care, Inc.5 sites in 1 country78 target enrollmentSeptember 11, 2017

ConditionsVisual Performance

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Visual Performance
Sponsor: Johnson & Johnson Vision Care, Inc.
Enrollment: 78
Locations: 5
Primary Endpoint: Distance Binocular Visual Acuity
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 11, 2017

End Date

November 4, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Johnson & Johnson Vision Care, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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).

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Distance Binocular Visual Acuity

Time Frame: 1-Week Follow-up

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.

Near Binocular Visual Acuity

Time Frame: 1-Week Follow-up

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