Evaluation of Toric Soft Contact Lenses Containing a Chromophore to Block High-Energy Visible Light Produced on Commercial Manufacturing Lines

Johnson & Johnson Vision Care, Inc.10 sites in 1 country126 target enrollmentMay 9, 2022

ConditionsVisual Acuity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.
Enrollment: 126
Locations: 10
Primary Endpoint: CLUE Comfort Score
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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..

Registry

clinicaltrials.gov

Start Date

May 9, 2022

End Date

August 9, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Johnson & Johnson Vision Care, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

CLUE Comfort Score

Time Frame: 1-Week Follow-up

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.