Evaluation of the Performance of Investigational Contact Lenses in a Presbyopic Population

Completed · Not applicable

Conditions studied: Presbyopia

In brief

The objective of this study is to evaluate the performance of a novel multifocal lens system.

Key facts

Study ID

NCT01763047

Run by

Johnson & Johnson Vision Care, Inc.

People needed

298

Starts

2012-11-01

Expected to finish

2013-02-01

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…

• Subjects must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• Subjects must appear able and willing to adhere to the instructions set forth in the clinical protocol.
• Subjects must be between 40 and 70 years of age.
• Subjects' spherical equivalent distance refraction must be in the range of -3.75 to +3.75 in each eye.
• Subjects' refractive cylinder must be less than or equal to 0.75D in each eye.
• Subjects' ADD power must be in the range of +0.75 to +2.50D in each eye.
• Subjects' must have the best corrected visual acuity of 20/20-3 or better in each eye.
• Subjects' should own a wearable pair of spectacles.
• Subjects' 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).
• Subjects' must respond positively to at least on symptom on the "Presbyopis Symptoms Questionnaire" or already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.).

You may not qualify if…

• Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
• Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
• Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
• Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
• 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.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• History of binocular vision abnormality or strabismus.
• Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV).
• History of diabetes.
• Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

Where it is running

• Study site — Mission Viejo, California, United States
• RPS — Jacksonville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Saint Augustine, Florida, United States
• Study site — Tallahassee, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Roswell, Georgia, United States
• Study site — Lutherville, Maryland, United States
• Study site — Closter, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Denver, North Carolina, United States
• Study site — Athens, Ohio, United States
• Study site — Kingston, Pennsylvania, United States
• Study site — Warwick, Rhode Island, United States
• Study site — Memphis, Tennessee, United States
• Study site — Amarillo, Texas, United States
• Study site — Tyler, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Salem, Virginia, United States

Full record on ClinicalTrials.gov

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