Visual Performance of Senofilcon A With and Without a New UV/HEV-filter

This study will occur in two non-dispensing phases: Phase 1 is a non-randomized, non-masked, non-dispensing study where subjects will wear their own contact lenses for approximately 1 hour. Phase 2 is a controlled, randomized, double-masked, contralateral non-dispensing study where the study lenses will be worn in a daily wear modality for approximately 3 hours.

Study Overview

• Status: Completed
• Conditions: Visual Performance
• Intervention / Treatment: Device: TRP-200; Device: ACUVUE Oasys 1-Day

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Athens, Georgia, United States, 30602
      • University of Georgia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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. For Phase I be between 18-39 (inclusive) years of age at the time of screening.
  4. For Phase II be between 18 and 70 (inclusive) years of age at the time of screening.
  5. 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.
  6. Possess a wearable pair of spectacles that provide correction for distance vision.
  7. Habitual spherical contact lens powers must be between -1.00 D and -6.00 D (inclusive) in each eye.
  8. For Phase I, habitual contact lenses must provide at least 20/20 acuity OD and OS.
  9. For Phase II, the spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 D and -6.00 D (inclusive) in each eye.
  10. For Phase II, the magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 D and 1.00 D (inclusive) in each eye.

  11. For Phase II, the best corrected, monocular, distance visual acuity must be 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. Be currently using any ocular medications or have any ocular infection of any type.
  3. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures.
  4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
  5. Be currently wearing monovision or multifocal contact lenses.
  6. Be currently wearing lenses in an extended wear modality.
  7. Have participated in a contact lens or lens care product clinical trial within 30 days prior to study enrollment.
  8. 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.
  9. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
  10. Have a history of strabismus or amblyopia.
  11. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
  12. Have had any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
  13. Have signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar).
  14. Have a history of eyelid injury, surgery or procedure that resulted in abnormal eyelid position or movement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEST/CONTROL; For Phase 2, eligible subjects that are enrolled will be randomized to the Test/Control contralateral sequence.	Device: TRP-200; JJVC Investigational Contact Lens; Other Names: TEST; Device: ACUVUE Oasys 1-Day; JJVC Marketed Contact Lens; Other Names: CONTROL
Experimental: CONTROL/TEST; For Phase 2, eligible subjects that are enrolled will be randomized to the Control/Test contralateral sequence.	Device: TRP-200; JJVC Investigational Contact Lens; Other Names: TEST; Device: ACUVUE Oasys 1-Day; JJVC Marketed Contact Lens; Other Names: CONTROL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Photopic Contrast Sensitivity at 6 Cpd	Photopic (~120 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2.	Post screening up to 1 hour during Phase 1
Mesopic Contrast Sensitivity at 6 Cpd	Mesopic (~3 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2.	Post screening up to 1 hour during Phase 1
Photopic Resolution Acuity Using Landolt C's With a Glare Source	Photopic resolution acuity using Landolt C's was measured separately for the right (OD) and left (OS) eyes, using an arcminute scale under bright light conditions (~120 cd/m2) with a broadband glare source. The photopic resolution acuity on arcminute scale was converted to logMAR scale for the analysis purpose using a log transformation. Lower values indicate better acuity.	At least 5 minutes post lens fitting up to 2 hours during Phase 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Photopic Contrast Sensitivity With a Glare Source	Photopic contrast sensitivity was measured for the right (OD) and left (OS) eyes separately under bright light conditions (~120 cd/m2) with a broadband glare source. Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. The area under the log contrast sensitivity function (AULCSF) was derived for the analysis using the trapezoidal rule. Higher AULCSF values indicate better contrast sensitivity.	At least 5 minutes post lens fitting up to 2 hours during Phase 2
Mesopic Contrast Sensitivity With a Glare Source	Mesopic contrast sensitivity was measured for the right (OD) and left (OS) eyes separately under dim light conditions (less than or equal 3 cd/m2) with a broadband glare source. Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. The area under the log contrast sensitivity function (AULCSF) was derived for the analysis using the trapezoidal rule. Higher AULCSF values indicate better contrast sensitivity.	At least 5 minutes post lens fitting up to 2 hours during Phase 2

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Actual): October 20, 2021
• Study Completion (Actual): October 20, 2021

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CR-6463

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