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

Visual Acuity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05344560
• Other study ID #: CR-6484
• Status: Completed
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: August 9, 2022

Study information

• Verified date: September 2023
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 9, 2022
• Est. primary completion date: August 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

Potential subjects must satisfy of all 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. 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.

5. Possess a wearable pair of spectacles that provide correction for distance vision.

6. In both eyes, have refractive error suitable for correction with the toric contact lens powers available in this study:

1. Sphere powers (DS) -1.50 through -4.00 in 0.25 steps

2. Cylinder powers (DC) -0.75 and -1.25

3. Axes (degrees) 170, 180, 10, 80, 90, 100

7. Have best corrected monocular distance visual acuity 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:

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. 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.

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.

7. Be currently wearing lenses in an extended wear modality.

8. Have a history of strabismus or amblyopia.

9. 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.

10. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.

Related Conditions & MeSH terms

• Visual Acuity

Intervention

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

Locations

Country	Name	City	State
United States	ProCare Vision Centers	Granville	Ohio
United States	Dr. James Weber & Associates, PA - City Square Blvd	Jacksonville	Florida
United States	Stam & Associates Eye Care	Jacksonville	Florida
United States	Sabal Eye Care	Longwood	Florida
United States	Maitland Vision Center - North Orlando Ave	Maitland	Florida
United States	Optometry Group, LLC	Memphis	Tennessee
United States	Southwest Orlando Eye Care	Orlando	Florida
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	Tyler Eye Associates	Tyler	Texas
United States	Dr. David W. Ferris & Associates	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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