Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes

Completed · Not applicable

Conditions studied: Vision Correction

In brief

The primary objective of this study is to determine the retention rate over a two month period of vision correction in emmetropic, presbyopes fitted with multifocal contact lenses.

Key facts

Study ID

NCT02394925

Run by

Johnson & Johnson Vision Care, Inc.

People needed

113

Starts

2015-01-01

Expected to finish

2015-09-01

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 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 40 and 70 years of age.
• The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to +2.00 in each eye.
• The subject's refractive cylinder must be less than or equal to -0.75 D in each eye.
• The subject's ADD power must be in the range of +0.75 D to +2.50.
• The subject must have best corrected visual acuity of 20/25 or better in each eye.

You may not qualify if…

• Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
• Any ocular or systemic allergies that contraindicate contact lens wear.
• Any ocular or systemic disease, autoimmune disease, or use of medication, that contraindicates contact lens wear.
• Any ocular abnormality that may interfere 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.).
• 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.
• History of herpetic keratitis.
• Any ocular infection or inflammation.
• Any corneal distortion or irregular cornea.
• 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.
• Current or previous history of being prescribed a correction for distance vision.
• Current or previous history of contact lens wear.
• Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

Where it is running

• Tallahassee Eye Center — Pensacola, Florida, United States
• Ocular Technology Group-International — London, United Kingdom

Full record on ClinicalTrials.gov

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