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

Study Overview
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Brief Summary
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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..

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

Conditions
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Visual Acuity

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


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test/control/control<br>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<br>* TEST Lens<br>Device: ACUVUE OASYS 1-Day for Astigmatism<br>* CONTROL Lens<br>|
| Experimental: control/test/test<br>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<br>* TEST Lens<br>Device: ACUVUE OASYS 1-Day for Astigmatism<br>* CONTROL Lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |