Evaluation of Toric Soft Contact Lenses Containing a Chromophore to Block High-Energy Visible Light

NCT05344560 | Completed Results FDA Device

• 1 other identifier: CR-6484
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 10

Brief Summary

This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing, 2-treament, 2-sequence, 3-period crossover study to evalulate overall vision and comfort..

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• CLUE Comfort Score

  Subjective comfort was assessed using Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (Comfort, Vision, Handling, and Packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution where scores range from 0 to 120 with a population average score of 60 (SD 20). Higher CLUE scores indicate a more favorable/positive response. The average CLUE comfort score was report for each lens type.

  1-Week Follow-up

Study Arms (2)

test/control/control

EXPERIMENTAL

Eligible subjects that are habitual contact lens wearers will be randomized into the (test/control/control) sequence and will wear two different study lenses one at a time bilaterally over three wear periods.

Device: soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore; Device: ACUVUE OASYS 1-Day for Astigmatism

control/test/test

EXPERIMENTAL

Eligible subjects that are habitual contact lens wearers will be randomized into the (control/test/test) sequence and will wear two different study lenses one at a time bilaterally over three wear periods.

Device: soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore; Device: ACUVUE OASYS 1-Day for Astigmatism

Interventions

soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore DEVICE

TEST Lens

control/test/test; test/control/control

ACUVUE OASYS 1-Day for Astigmatism DEVICE

CONTROL Lens

control/test/test; test/control/control

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Potential subjects must satisfy of all the following criteria to be enrolled in the study.
• 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.
• Be between 18 and 39 years of age (inclusive) at the time of screening.
• By self-report, habitually wear soft contact lenses in both eyes in a daily or daily disposable wear modality (i.e. not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past four weeks.
• Possess a wearable pair of spectacles that provide correction for distance vision.
• In both eyes, have refractive error suitable for correction with the toric contact lens powers available in this study:
• Sphere powers (DS) -1.50 through -4.00 in 0.25 steps
• Cylinder powers (DC) -0.75 and -1.25
• Axes (degrees) 170, 180, 10, 80, 90, 100
• Have best corrected monocular distance visual acuity of 20/30 or better in each eye.

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Be currently pregnant or lactating.
• Be diabetic.
• Be currently using any ocular medications or have an ocular infection of any type.
• 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.
• Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
• Be currently wearing monovision or multifocal contact lenses.
• Be currently wearing lenses in an extended wear modality.
• Have a history of strabismus or amblyopia.
• 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.
• Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (10)

Dr. James Weber & Associates, PA - City Square Blvd

Jacksonville, Florida, 32218, United States

Location

Stam & Associates Eye Care

Jacksonville, Florida, 32256, United States

Location

Sabal Eye Care

Longwood, Florida, 32779, United States

Location

Maitland Vision Center - North Orlando Ave

Maitland, Florida, 32751, United States

Location

Southwest Orlando Eye Care

Orlando, Florida, 32819, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

ProCare Vision Centers

Granville, Ohio, 43023, United States

Location

Dr. David W. Ferris & Associates

Warwick, Rhode Island, 02888, United States

Location

Optometry Group, LLC

Memphis, Tennessee, 38111, United States

Location

Tyler Eye Associates

Tyler, Texas, 75703, United States

Location

MeSH Terms

Interventions

Contact Lenses, Hydrophilic

Intervention Hierarchy (Ancestors)

Contact Lenses; Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Benjamin Straker
• Organization: Johnson & Johnson Vision Care, Inc. (JJVC)

bstraker@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: April 19, 2022
• First Posted: April 25, 2022
• Study Start: May 9, 2022
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2022
• Last Updated: September 15, 2023
• Results First Posted: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

US (10)