Clinical Performance of Two Daily Disposable Silicone Hydrogel Contact Lenses

NCT05554640 | Completed Results FDA Device

• 1 other identifier: CR-6495
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Test/Control

EXPERIMENTAL

Eligible subjects that are habitual contact lens wearers will be randomized into the sequence, Test/Control.

Device: Acuvue® Oasys MAX 1-Day; Device: Dailies Total 1

Control/Test

EXPERIMENTAL

Eligible subjects that are habitual contact lens wearers will be randomized into the sequence, Test/Control.

Device: Acuvue® Oasys MAX 1-Day; Device: Dailies Total 1

Interventions

Acuvue® Oasys MAX 1-Day DEVICE

TEST Lens

Control/Test; Test/Control

Dailies Total 1 DEVICE

CONTROL Lens

Control/Test; Test/Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• Appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Between 18 and 40 (inclusive) years of age at the time of screening.
• They agree not to participate in other clinical research while enrolled on this study.
• 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.
• They own a wearable pair of spectacles if needed for distance vision correction (by self-report).
• They can attain a best-corrected logMAR distance visual acuity of at least 0.20 in each eye.
• They have spherical contact lens prescription in the range -1.00 to -6.00 DS (based on the calculated ocular refraction).
• They have up to maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction).

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Currently pregnant or lactating.
• 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.
• They have an ocular disorder which would normally contraindicate contact lens wear.
• They have had cataract surgery.
• They have had corneal refractive surgery.
• They are using any topical medications such as eye drops or ointments.
• Any known hypersensitivity or allergic reaction to sodium fluorescein.
• 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.
• Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
• Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
• They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
• 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

The University of Manchester

Manchester, M13 9PL, United Kingdom

Location

Results Point of Contact

• Title: John R. Buch, O.D., M.S.
• Organization: Johnson & Johnson Vision Care (JJVC)

jbuch@its.jnj.com

1-800-843-2020

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 26, 2022
• Study Start: October 24, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 20, 2023
• Results First Posted: December 20, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)