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Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes

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ClinicalTrials.gov Identifier: NCT02394925
Recruitment Status : Completed
First Posted : March 20, 2015
Results First Posted : May 15, 2017
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Vision Correction Device: Multifocal Test Contact lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : September 1, 2015
Actual Study Completion Date : September 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Multifocal Test Contact Lens
Subjects will wear the test lenses at least six hours per day, at least five days per week
Device: Multifocal Test Contact lens
Used in a daily wear modality
Other Name: etafilcon A




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The subject must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.
  2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. The subject must be between 40 and 70 years of age.
  4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to +2.00 in each eye.
  5. The subject's refractive cylinder must be less than or equal to -0.75 D in each eye.
  6. The subject's ADD power must be in the range of +0.75 D to +2.50.
  7. The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

  1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
  2. Any ocular or systemic allergies that contraindicate contact lens wear.
  3. Any ocular or systemic disease, autoimmune disease, or use of medication, that contraindicates contact lens wear.
  4. Any ocular abnormality that may interfere with contact lens wear.
  5. Use of any ocular medication, with the exception of rewetting drops.
  6. Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
  7. 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.
  8. History of herpetic keratitis.
  9. Any ocular infection or inflammation.
  10. Any corneal distortion or irregular cornea.
  11. History of binocular vision abnormality or strabismus.
  12. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV).
  13. History of diabetes.
  14. Current or previous history of being prescribed a correction for distance vision.
  15. Current or previous history of contact lens wear.
  16. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394925


Locations
United States, Florida
Tallahassee Eye Center
Pensacola, Florida, United States, 32503
United Kingdom
Ocular Technology Group-International
London, United Kingdom, SW1E 6AU
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT02394925     History of Changes
Other Study ID Numbers: CR-5672
First Posted: March 20, 2015    Key Record Dates
Results First Posted: May 15, 2017
Last Update Posted: June 19, 2018
Last Verified: April 2017