Clinical Evaluation of Investigational Multifocal Contact Lenses

Johnson & Johnson Vision Care, Inc.9 sites in 1 country72 target enrollmentJanuary 27, 2017

ConditionsVisual Acuity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.
Enrollment: 72
Locations: 9
Primary Endpoint: Overall Vision
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

3-visit dispensing study to evaluate the subjective feedback of a multifocal contact lens in a population of presbyopic patients. Subjects will wear the contact lenses for a total of 12-16 days.

Registry

clinicaltrials.gov

Start Date

January 27, 2017

End Date

April 25, 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Johnson & Johnson Vision Care, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Healthy adult males or females that are at least 40 years of age and no more than 70 years of age.
•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 if not, respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".(Appendix B).
•The subject is a current soft spherical or toric contact lens wearer (defined as a minimum of 6 hours of wear per day at least two days of the week for a minimum of 1 month prior to the study).
•The subject's refractive spherical component must be between +1.25 Diopters (D) to +3.75 D in each eye.
•The subject's refractive cylinder must be -1.00 D to -1.50 D in each eye.
•The subject's refractive cylinder axis must be 90°±30° or 180°±30° 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 distance visual acuity of 20/20-3 or better in each eye.

Exclusion Criteria

•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, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (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.

Outcomes

Primary Outcomes

Overall Vision

Time Frame: 12-16 Day Follow-up

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.