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Evaluation of Two Marketed Multifocal Contact Lenses

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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.

Tracking Information
First Submitted Date  ICMJE September 28, 2017
First Posted Date  ICMJE October 26, 2017
Results First Submitted Date  ICMJE October 31, 2018
Results First Posted Date  ICMJE January 8, 2019
Last Update Posted Date January 8, 2019
Actual Study Start Date  ICMJE September 11, 2017
Actual Primary Completion Date November 4, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2017)
  • Visual Performance [ Time Frame: 8-12 days of wear ]
    Distance binocular high luminance, high contrast visual performance on logMAR (logMAR-Logarithm of Minimal Angle of Resolution) scale will be assessed for each subject after 8-12 days of wear. Visual performance will be recorded OD, OS, and OU. For Distance, Bright Illuminance, ETDRS 3Meter-High Contrast charts will be used. Visual acuity is scored with reference to logMAR-Logarithm of Minimal Angle of Resolution. Each letter has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR Chart(s) represents a change of 0.1 log units. The score for each line is aggregated for a total visual performance score with that chart and lighting condition.
  • Visual Performance [ Time Frame: 8-12 days of wear ]
    Near binocular high luminance, high contrast visual performance on logMAR (logMAR-Logarithm of Minimal Angle of Resolution) scale will be assessed for each subject after 8-12 days of wear. Visual performance will be recorded OD, OS, and OU. For Near, Bright Illuminance, Reduced Guillon-Poling High Contrast and Intermediate (64cm) and Near (40cm) charts will be used. Visual acuity is scored with reference to logMAR-Logarithm of Minimal Angle of Resolution. Each letter has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR Chart(s) represents a change of 0.1 log units. The score for each line is aggregated for a total visual performance score with that chart and lighting condition.
Change History Complete list of historical versions of study NCT03322423 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2017)
Vision and Handling [ Time Frame: 8-12 days of wear ]
Overall Quality of vision and handling scores are assessed using the Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response (2016).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Two Marketed Multifocal Contact Lenses
Official Title  ICMJE Evaluation of Two Marketed Multifocal Contact Lenses
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Visual Performance
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Multifocal Contact Lens 1
    • Device: Multifocal Contact Lens 2
    • Device: Spherical Contact Lens 2
  • 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.
    Interventions:
    • Device: Multifocal Contact Lens 1
    • Device: Multifocal Contact Lens 2
    • Device: Spherical Contact Lens 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2017)
78
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2017)
80
Actual Study Completion Date  ICMJE November 4, 2017
Actual Primary Completion Date November 4, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03322423
Other Study ID Numbers  ICMJE CR-5860
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johnson & Johnson Vision Care, Inc.
Study Sponsor  ICMJE Johnson & Johnson Vision Care, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Johnson & Johnson Vision Care, Inc.
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP