Evaluation of ACUVUE® OASYS 1-Day for Astigmatism Contact Lenses With Alternative Lidstock

This will be a single-visit, randomized, double-masked, bilateral wear, non-dispensing, 2-sequence × 2-period crossover study to evaluate subject reported ocular symptoms.

Study Overview

• Status: Completed
• Conditions: Ocular Physiology
• Intervention / Treatment: Device: Acuvue Oasys 1 Day for Astigmatism with Legacy lidstock; Device: Acuvue Oasys 1 Day for Astigmatism with Amcor laminated lidstock

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32256
      • VRC

Participation Criteria

Eligibility Criteria

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

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 years of age (inclusive) at the time of screening.
  4. Habitually wear soft contact lenses (either sphere or toric) 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 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. Have the spherical component of their vertex-corrected distance refraction within the range +4.00 to -9.00 DS (inclusive) in both eyes.
  7. Have the magnitude of the cylindrical component of their vertex-corrected distance refraction below 3.00 DC (inclusive) in both eyes.
  8. Have best corrected monocular distance VA 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 an ocular infection of any type.
4. Have any ocular or systemic allergies, disease, infection, or use of medication that might contraindicate or interfere with contact lens wear or otherwise compromise study endpoints, including infectious diseases (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), or history of serious mental illness or seizures. See section 9.1 for additional details regarding 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 or be currently wearing lenses in an extended wear modality.
7. Have a history of strabismus or amblyopia.
8. Be an employee (e.g., Investigator, Coordinator, Technician) or family member of an employee of investigational clinic.
9. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
10. Have clinically significant (Grade 3 or 4 on the FDA classification 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 may contraindicate contact lens wear or otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
11. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
12. Have had or have planned (within the study period) ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, 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) with a washout period of 15 minutes between wears. During each wear period the lenses will be worn bilaterally for at least one hour in-office.	Device: Acuvue Oasys 1 Day for Astigmatism with Legacy lidstock; CONTROL; Device: Acuvue Oasys 1 Day for Astigmatism with Amcor laminated lidstock; TEST
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) with a washout period of 15 minutes between wears. During each wear period the lenses will be worn bilaterally for at least one hour in-office.	Device: Acuvue Oasys 1 Day for Astigmatism with Legacy lidstock; CONTROL; Device: Acuvue Oasys 1 Day for Astigmatism with Amcor laminated lidstock; TEST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Eyes With Moderate or Severe Subject-Reported Ocular Symptoms	Ocular symptoms were assessed using open-ended question. Investigators asked each subject if they experienced any eye symptoms or problems with lens wear when wearing the study lenses. If responded "Yes", then subject characterized each symptom to the following scale for each eye: 0 = Not Applicable or Not Recorded, 1 = Mild and results in little or no interference with lens wear, 2 = Moderate AND/OR occasionally interferes with lens wear, and 3 = Severe AND/OR frequently interferes with lens wear. Investigators classified each subject reported symptom into these categories: Burning/stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision, and Other. The data was dichotomized across all symptoms, where Y=1 if any "moderate" or "severe" ocular symptoms were reported and Y=0 otherwise. The proportion of eyes with any "moderate" or "severe" ocular symptoms was reported for each lens.	Up to 1-Hour Follow-Up

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): January 30, 2023
• Primary Completion (Actual): February 9, 2023
• Study Completion (Actual): February 9, 2023

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: CR-6530

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