Clinical Performance of Two Daily Disposable Silicone Hydrogel Contact Lenses

This is a subject-masked, randomized, bilateral, 2x2 crossover clinical investigation that will assess lens fit acceptance.

Study Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Device: Acuvue® Oasys MAX 1-Day; Device: Dailies Total 1

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9PL
    • The University of Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 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. The subject must 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. Between 18 and 40 (inclusive) years of age at the time of screening.
  4. They agree not to participate in other clinical research while enrolled on this study.
  5. They have worn the same brand of soft daily disposable silicone hydrogel contact lenses at least eight hours per day for at least four days per week over the past 4 weeks.
  6. They own a wearable pair of spectacles if needed for distance vision correction (by self-report).
  7. They can attain a best-corrected logMAR distance visual acuity of at least 0.20 in each eye.
  8. They have spherical contact lens prescription in the range -1.00 to -6.00 DS (based on the calculated ocular refraction).

  9. They have up to maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction).

     Exclusion Criteria:

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

  1. Currently pregnant or lactating.
  2. Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g., rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study or may pose a risk to study personnel.
  3. They have an ocular disorder which would normally contraindicate contact lens wear.
  4. They have had cataract surgery.
  5. They have had corneal refractive surgery.
  6. They are using any topical medications such as eye drops or ointments.
  7. Any known hypersensitivity or allergic reaction to sodium fluorescein.
  8. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear. See section 9.1 for additional details regarding excluded systemic medications.
  9. Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
  10. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  11. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  12. Any Efron Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection), 13. They have a pre-corneal tear film break-up time less than five seconds when evaluated on the DESMD tear film imaging system.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test/Control; Eligible subjects that are habitual contact lens wearers will be randomized into the sequence, Test/Control.	Device: Acuvue® Oasys MAX 1-Day; TEST Lens; Device: Dailies Total 1; CONTROL Lens
Experimental: Control/Test; Eligible subjects that are habitual contact lens wearers will be randomized into the sequence, Test/Control.	Device: Acuvue® Oasys MAX 1-Day; TEST Lens; Device: Dailies Total 1; CONTROL Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Eyes With Acceptable Lens Fitting	Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion, the 1- and 2-week follow-up evaluations and any unscheduled visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported.	Up to 2-Week 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): October 24, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CR-6495

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