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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Visual Acuity

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05344560

CR-6484

Details and patient eligibility

About

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..

Enrollment: 126 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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126 participants in 2 patient groups

test/control/control

Experimental group

Description:

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.

Treatment:

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

Device: ACUVUE OASYS 1-Day for Astigmatism

control/test/test

Experimental group

Description:

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.

Treatment:

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

Device: ACUVUE OASYS 1-Day for Astigmatism