Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over Two Weeks of Wear

This will be a multi-site, bilateral, dispensing, randomized, controlled, double-masked, 2×2 crossover study to evaluate ocular physiological response.

Study Overview

• Status: Completed
• Conditions: Ocular Physiology
• Intervention / Treatment: Device: Senofilcon A contact lenses (TEST); Device: Delefilcon A contact lenses (CONTROL)

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 1-800-843-2020; Email: bstraker@its.jnj.com

Study Locations

• United States
  • Florida
    • Longwood, Florida, United States, 32779
      • Omega Vision Center
    • Maitland, Florida, United States, 32751
      • Maitland Vision Center - North Orlando Ave
  • Ohio
    • Granville, Ohio, United States, 43023
      • Procare Vision Centers
    • Westerville, Ohio, United States, 43081
      • Professional Vision Care Inc. - Westerville
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Optometry Group, LLC
  • Texas
    • Tyler, Texas, United States, 75703
      • Tyler Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

The subject must:

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 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 2 days per week during the past four weeks.
5. Possess a wearable pair of spectacles that provide correction for distance vision.

6. In both eyes, have refractive error suitable for correction with the toric contact lens powers available in this study:

   1. Sphere powers (DS) -1.50 through -4.00 in 0.25 steps
   2. Cylinder powers (DC) -0.75 and -1.25
   3. Axes (°) 170, 180, 10, 80, 90, 100
7. Have best corrected monocular distance visual acuity of 20/30 or better in each eye.

Exclusion Criteria:

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

The subject must not:

1. Be currently pregnant or lactating.
2. Be diabetic.
3. Be currently using any ocular medications or have any ocular infection of any type.
4. 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. See section 9.1 for additional details regarding excluded systemic medications.
5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months.
6. Be currently wearing monovision or multifocal contact lenses.
7. Be currently wearing lenses in an extended wear modality.
8. Have a history of strabismus or amblyopia.
9. 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.
10. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
11. 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).
12. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
13. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test/Control; Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to wear two different study lenses, one at a time, over two wear periods (test then control). Each wear period will be approximately 2 weeks in duration, with a washout period of approximately 1 week between wear periods. Subjects will be advised to wear the study lenses for a minimum of 8 hours per day on at least 5 days per week of each wear period.	Device: Senofilcon A contact lenses (TEST); Rotationally stabilized astigmatic soft contact lenses in senofilcon A containing a chromophore to filter High-Energy Visible Light (HEVL); Device: Delefilcon A contact lenses (CONTROL); DAILIES TOTAL1® for Astigmatism Contact Lenses (DT1fA)
Experimental: Control/Test; Eligible subjects who are habitual soft contact lens wearers will be randomized into the Control/Test sequence, to wear two different study lenses, one at a time, over two wear periods (control then test). Each wear period will be approximately 2 weeks in duration, with a washout period of approximately 1 week between wear periods. Subjects will be advised to wear the study lenses for a minimum of 8 hours per day on at least 5 days per week of each wear period.	Device: Senofilcon A contact lenses (TEST); Rotationally stabilized astigmatic soft contact lenses in senofilcon A containing a chromophore to filter High-Energy Visible Light (HEVL); Device: Delefilcon A contact lenses (CONTROL); DAILIES TOTAL1® for Astigmatism Contact Lenses (DT1fA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slit Lamp Examination Findings (SLF)	Percentage of eyes with Grade 3 or higher SLFs related to study lens wear after 2 weeks of lens wear. SLFs will be evaluated and classified using the FDA Grading scale rating from 0 to 4, where Grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e., Grade 1=trace, Grade 2= mild, Grade 3=moderate and Grade 4= severe).	After 2 weeks of contact lens wear for each study lens

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Investigators: Study Director: Johnson & Johnson Vision Care, Inc. Clinical Trial, Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2023
• Primary Completion (Actual): February 13, 2024
• Study Completion (Actual): February 13, 2024

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CR-6553

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