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Marketed Contact Lens Real World Through Focus Curve

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679976
Recruitment Status : Completed
First Posted : February 11, 2016
Results First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
This is a single-visit prospective study to establish a real world Marketed Contact Lens 'Through Focus Curve' (TFC) measurement by comparing the consistency of vision between myopes and hyperopes. 33 subjects will be enrolled (at least 15 myopes and 15 hyperopes), who are 40 years of age or older, for a 1-visit, 4-hour study for measurements to be taken.

Condition or disease Intervention/treatment Phase
Visual Acuity Device: etafilcon A Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Study Lens (etafilcon A) for Multifocal
All Subjects in this study will wear the same contact lenses. However subjects wil be stratified as Hyperopes or Myopes using a 1:1 allocation. The study lens will be worn for a period of approximately 4 hours to allow lenses to settle on the eyes.
Device: etafilcon A
Marketed Multifocal Contact Lens




Primary Outcome Measures :
  1. Distance Binocular LogMAR Visual Acuity [ Time Frame: 4 Hr. Post Fitting ]
    Distance Binocular LogMAR Visual Acuity was measured at 4m for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )

  2. Near Binocular LogMAR Visual Acuity [ Time Frame: 4 Hr. Post Fitting ]
    Near Binocular LogMAR Visual Acuity was measured at 40cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )

  3. Intermediate Binocular LogMAR Visual Acuity [ Time Frame: 4 Hr. Post Fitting ]
    intermediate Binocular LogMAR Visual Acuity was measured at 67cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 ≥40 years of age.
  • The subjects' optimal vertexed spherical equivalent distance correction must be between -6.00 Diopters (D) and +4.00 D in each eye.
  • The subject's refractive cylinder must be ≤ -0.75 D in each eye.
  • The subject's ADD power must be in the range of +0.75 to +2.50 D in each eye.
  • The subject must have best corrected visual acuity of 20/25 or better for each eye.
  • The subject can be either a new contact lens wearer or an existing soft contact lens wearer.

Exclusion Criteria:

  • Currently pregnant or lactating.
  • 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, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
  • Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, and 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.
  • Participant in unrelated research involving test product within 30 days before planned study visit.

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): NCT02679976


Locations
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United Kingdom
Optometry Technology Group, Ltd.
London, United Kingdom, SW1E 6AU
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT02679976    
Other Study ID Numbers: CR-5728
First Posted: February 11, 2016    Key Record Dates
Results First Posted: September 15, 2016
Last Update Posted: September 15, 2016
Last Verified: July 2016