Evaluation of an Investigational Multifocal Lens

Completed · Not applicable

Conditions studied: Presbyopia

In brief

The purpose of this study is to test the performance of an investigational multifocal test soft contact lens.

Key facts

Study ID

NCT02223754

Run by

Johnson & Johnson Vision Care, Inc.

People needed

371

Starts

2014-08-01

Expected to finish

2014-11-01

Last updated by the study team

2018-06-19

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The subjects were required to have read, understand, and signed 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.
• Between 40 and 70 years of age.
• Subjects must own a wearable pair of spectacles, if required for their distance vision.
• 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)
• 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"*
• The subject's vertex corrected spherical equivalent distance refraction was required to be in the range +3.50 to -5.75 in each eye.
• Refractive cylinder ≤ -0.75 D in each eye.
• ADD power in the range +0.75 D to +2.50 D in each eye.
• Best corrected visual acuity of 20/20-3 or better in each eye.

You may not qualify if…

• Currently pregnant or lactating (subjects who became pregnant during the study were discontinued).
• Any ocular or systemic allergies that may have contraindicated contact lens wear.
• Any ocular or systemic disease, autoimmune disease, or use of medication, that may have contraindicated contact lens wear.
• Any ocular abnormality that may have interfered with contact lens wear.
• Use of any ocular medication, with the exception of rewetting drops.
• Any previous intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
• History of herpetic keratitis.
• History of binocular vision abnormality or strabismus.
• Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).
• History of diabetes.
• Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
• Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
• Any ocular infection or inflammation.
• Any corneal distortion or irregular cornea.

Where it is running

• Study site — Montgomery, Alabama, United States
• Study site — Mission Viejo, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Orange Park, Florida, United States
• Study site — Saint Augustine, Florida, United States
• Study site — Tallahassee, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Roswell, Georgia, United States
• Study site — Pittsburg, Kansas, United States
• Study site — East Lansing, Michigan, United States
• Study site — Vestal, New York, United States
• Study site — Denver, North Carolina, United States
• Study site — Powell, Ohio, United States
• Study site — Springfield, Ohio, United States
• Study site — Warwick, Rhode Island, United States
• Study site — Memphis, Tennessee, United States
• Study site — Tyler, Texas, United States
• Study site — Salem, Virginia, United States

Full record on ClinicalTrials.gov

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