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Evaluation of Two Marketed Multifocal Contact Lenses

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: NCT03322423
Recruitment Status : Completed
First Posted : October 26, 2017
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
This is a single-masked, randomized, cross-over, dispensing, 6- visit pilot study. The purpose of this clinical study is to evaluate the performance of two marketed multifocal lenses.

Condition or disease Intervention/treatment Phase
Visual Performance Device: Multifocal Contact Lens 1 Device: Multifocal Contact Lens 2 Device: Spherical Contact Lens 2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Two Marketed Multifocal Contact Lenses
Actual Study Start Date : September 11, 2017
Actual Primary Completion Date : November 4, 2017
Actual Study Completion Date : November 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Active Comparator: Test 1 Multifocal/Test 2 Multifocal OR Test 2 Alternative
Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 1 Multifocal then Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power), for approximately 8-12 days of wear with an approximately 4-8 day washout period.
Device: Multifocal Contact Lens 1
Dailies Total 1 Multifocal Contact Lens
Other Name: Test 1 Multifocal , delefilcon A

Device: Multifocal Contact Lens 2
Biotrue ONEday for Presbyopia Contact Lenses
Other Name: Test 2 Multifocal, nesofilcon A

Device: Spherical Contact Lens 2
BioTrue ONEDay Spherical
Other Name: Test 2 Alternative, nesofilcon A

Active Comparator: Test 2 Multifocal OR Test 2 Alternative/Test 1 Multifocal
Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power) then Test 1 Multifocal, for approximately 8-12 days of wear with an approximately 4-8 day washout period.
Device: Multifocal Contact Lens 1
Dailies Total 1 Multifocal Contact Lens
Other Name: Test 1 Multifocal , delefilcon A

Device: Multifocal Contact Lens 2
Biotrue ONEday for Presbyopia Contact Lenses
Other Name: Test 2 Multifocal, nesofilcon A

Device: Spherical Contact Lens 2
BioTrue ONEDay Spherical
Other Name: Test 2 Alternative, nesofilcon A




Primary Outcome Measures :
  1. Distance Binocular Visual Acuity [ Time Frame: 1-Week Follow-up ]
    Distance visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts.

  2. Near Binocular Visual Acuity [ Time Frame: 1-Week Follow-up ]
    Near visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using reduced Guillon-Poling Charts.


Secondary Outcome Measures :
  1. Overall Quality of Vision [ Time Frame: 1-Week Follow-up ]
    Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.



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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:

  • Potential subjects must satisfy all of the following criteria to be enrolled in the study:

    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 at least 40 years of age and not greater than 70 years of age.
    4. The subject's distance spherical equivalent refraction must be in the range of +3.75 D to -3.75 D.
    5. The subject's refractive cylinder must be ≤ -0.75 D in each eye.
    6. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
    7. The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
    8. The subject must own a pair of wearable spectacles if required for their distance vision.
    9. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration).
    10. The subject must either be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".

      Exclusion Criteria:

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:

    1. Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.
    2. Pregnancy or lactation.
    3. Currently diagnosed with diabetes.
    4. Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).
    5. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
    6. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
    7. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
    8. A history of amblyopia, strabismus or binocular vision abnormality.
    9. Any ocular infection or inflammation.
    10. Any ocular abnormality that may interfere with contact lens wear.
    11. Use of any ocular medication, with the exception of rewetting drops.
    12. History of herpetic keratitis.
    13. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
    14. Employee of clinical site (e.g., Investigator, Coordinator, Technician)

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): NCT03322423


Locations
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United States, Florida
Golden Vision
Sarasota, Florida, United States, 34232
United States, New Mexico
ABQ Eye Care
Albuquerque, New Mexico, United States, 87109
United States, New York
Sacco Eye Group
Vestal, New York, United States, 13850
United States, Rhode Island
West Bay Eye Associates
Warwick, Rhode Island, United States, 02888
United States, Virginia
Botetourt Eyecare, LLC
Salem, Virginia, United States, 24153
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
  Study Documents (Full-Text)

Documents provided by Johnson & Johnson Vision Care, Inc.:

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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT03322423     History of Changes
Other Study ID Numbers: CR-5860
First Posted: October 26, 2017    Key Record Dates
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes