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Effects of Multifocal Contact Lens on Ocular Tissue

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ClinicalTrials.gov Identifier: NCT02345720
Recruitment Status : Completed
First Posted : January 26, 2015
Results First Posted : October 5, 2016
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
The purpose of this study is to evaluate the etafilcon - PVP (multi-focal)

Condition or disease Intervention/treatment Phase
Visual Acuity Device: etafilcon - PVP (multi-focal) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects on Ocular Tissues of Vistakon® Investigational Multifocal Contact Lenses - Asian Population Study
Study Start Date : December 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: etafilcon - PVP (multi-focal)
The investigational soft contact lenses will be worn in a daily wear modality for 30 days over the course of the study.
Device: etafilcon - PVP (multi-focal)
The investigational contact lens must be worn at least six hours daily.




Primary Outcome Measures :
  1. Upper Eye Lid Margin Staining [ Time Frame: 30 days Post wear ]
    Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm^2.

  2. Limbal Staining [ Time Frame: 30 Days Post Wear ]
    Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported.

  3. Corneal Staining [ Time Frame: 30 Days Post Wear ]
    The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported.



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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 too -5.75 in each eye.
  5. The subject must identify themselves as Asian by self-report and have eyes and eyelids with an automatically Asian appearance.
  6. The subject's refractive cylinder must be less than or equal to -0.75D in each eye.
  7. The subject's ADD power must be in the range of +0.75 D to +2.5 D in each eye.
  8. The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
  9. Subjects own a wearable pair of spectacles, if required for their distance vision.
  10. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 5 days per week for at least 8 hours per day, for one month or more duration).
  11. The subject must already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".

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 will contraindicate contact lens wear.
  4. Any ocular abnormality that may interfere with contact lens wear.
  5. Use of any ocular medications, 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. Habitual wearer of etafilcon-A contact lens material.
  15. 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): NCT02345720


Locations
United Kingdom
London, United Kingdom, SW1E6AU
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT02345720     History of Changes
Other Study ID Numbers: CR-5632
First Posted: January 26, 2015    Key Record Dates
Results First Posted: October 5, 2016
Last Update Posted: June 19, 2018
Last Verified: October 2016