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

Not Applicable

Completed

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

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..

Recruitment & Eligibility

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:
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
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:

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.

Arm && Interventions

Group	Intervention	Description
test/control/control	ACUVUE OASYS 1-Day for Astigmatism	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.
test/control/control	soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore	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.
control/test/test	ACUVUE OASYS 1-Day for Astigmatism	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.
control/test/test	soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore	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.

Primary Outcome Measures

Name	Time	Method
CLUE Comfort Score	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.

Secondary Outcome Measures

Name	Time	Method

Locations (10): Tyler Eye Associates
🇺🇸
Tyler, Texas, United States
Dr. James Weber & Associates, PA - City Square Blvd
🇺🇸
Jacksonville, Florida, United States
Sabal Eye Care
🇺🇸
Longwood, Florida, United States
Dr. David W. Ferris & Associates
🇺🇸
Warwick, Rhode Island, United States
Maitland Vision Center - North Orlando Ave
🇺🇸
Maitland, Florida, United States
ProCare Vision Centers
🇺🇸
Granville, Ohio, United States
Southwest Orlando Eye Care
🇺🇸
Orlando, Florida, United States
Stam & Associates Eye Care
🇺🇸
Jacksonville, Florida, United States
Optometry Group, LLC
🇺🇸
Memphis, Tennessee, United States
Kannarr Eye Care
🇺🇸
Pittsburg, Kansas, United States