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Completed

NCT Number: NCT02394925

Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes

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.

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Key information

Conditions

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ocular Technology Group-International, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multifocal Test Contact lens

Device

Used in a daily wear modality

Other names: etafilcon A

Primary outcomes

  1. Proportion of Successful Contact Lens Wearers

    Time frame: 2 months post wear

    Proportion of Successful contact lens wearers is based on a subject's responses to two questionnaire items, "Overall Quality of Vision" and "Overall Comfort". Each item uses a 6 response like-rt scale (0= Not Applicable, 1=Excellent, 2=Very Good, 3=Good, 4=Fair and 5=Poor). The data from each item was dichotomized into two groups. If a subject responded "Excellent", "Very Good" or "Good" then the response=1, otherwise the response=0. The proportion of subjects with response=1 was reported as the proportion of successful contact lens wearers.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 20, 2015
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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