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N/A N=108 Treatment

Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes

Vision Correction

Enrolled (actual)
108
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Proportion of Successful Contact Lens Wearers — 0.71 Proportion of Subjects

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Multifocal Test Contact lens (Device)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
Johnson & Johnson Vision Care, Inc.
Primary completion
Sep 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Proportion of Successful Contact Lens Wearers
0.71

Summary

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.

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.
  • 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.

Exclusion Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02394925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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