Evaluation of Prototype Lenses With Experimental UV/HEV Blocker

This is a bilateral, 2-week dispensing, randomized, controlled, subject-masked, 2×2 crossover study to evaluate the clinical performance of prototype contact lenses with experimental UV/HEV-blocker.

Study Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Device: TRP-200; Device: JJVC Marketed Contact Lens

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32205
      • Dr. James Weber & Associates, PA
    • Orange Park, Florida, United States, 32073
      • Flora Chen Poveda, OD, PA
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Eye Center
  • Georgia
    • Roswell, Georgia, United States, 30075
      • Visual Eyes
  • Michigan
    • Bloomfield Township, Michigan, United States, 48301
      • Birmingham Vision Care
  • Minnesota
    • Medina, Minnesota, United States, 55340
      • Complete Eye Care of Medina
  • New Jersey
    • Closter, New Jersey, United States, 07624
      • Dr. Debbie H. Kim, OD
  • Ohio
    • Westerville, Ohio, United States, 43081
      • Professional Vision Care, Inc.
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Optometry Group, LLC
  • Texas
    • Houston, Texas, United States, 77054
      • Gulf Coast Vision Center, Inc.
    • Tyler, Texas, United States, 75703
      • Frazier Vision, Inc.
  • Virginia
    • Salem, Virginia, United States, 24153
      • Botetourt Eyecare, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

  1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Be between 18 and 39 (inclusive) years of age at the time of screening.
  4. By self-report, habitually wear spherical silicone hydrogel soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.
  5. Have a habitual contact lens prescription that is current within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.
  6. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D (except -5.00 D) in both eyes.
  7. The subject's refractive cylinder must be 1.00 D or less.

  8. The subject must have best corrected visual acuity of 20/25 or better in each eye.

     Exclusion Criteria:

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

  1. Be currently pregnant or lactating.
  2. Have any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  3. Have any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
  4. Have any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  5. Be currently wearing lenses in a monovision, multi-focal, toric, or extended wear modality.
  6. Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  7. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
  8. Have a history of binocular vision abnormality or strabismus.
  9. Have any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
  10. Have any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
  11. Have any ocular infection.
  12. Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  13. Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test/Control; Eligible subjects will be randomized into one of two possible lens wear sequences, Test/Control.	Device: TRP-200; JJVC Investigational Contact Lens; Other Names: TEST Lens; Device: JJVC Marketed Contact Lens; ACUVUE Oasys 1-Day; Other Names: CONTROL Lens
EXPERIMENTAL: Control/Test; Eligible subjects will be randomized into one of two possible lens wear sequences, Control/Test.	Device: TRP-200; JJVC Investigational Contact Lens; Other Names: TEST Lens; Device: JJVC Marketed Contact Lens; ACUVUE Oasys 1-Day; Other Names: CONTROL Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Quality of Vision Score	Overall quality of vision scores were 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. The average CLUE vision score for each lens type was reported.	2-Week Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Comfort Scores	Overall comfort scores were 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. The average CLUE comfort score for each lens type was reported.	2-Week Follow-up
Overall Handling Scores	Overall handling scores were 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. The average CLUE handling score for each lens type was reported.	2-Week Follow-up

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 10, 2021
• Primary Completion (ACTUAL): August 9, 2021
• Study Completion (ACTUAL): August 9, 2021

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (ACTUAL): May 13, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CR-6437

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes