Evaluation of ACUVUE® OASYS 1-Day for Astigmatism Contact Lenses With Alternative Lidstock

Study Overview
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Brief Summary
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This will be a single-visit, randomized, double-masked, bilateral wear, non-dispensing, 2-sequence × 2-period crossover study to evaluate subject reported ocular symptoms.

Official Title
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Evaluation of ACUVUE® OASYS 1-Day for Astigmatism Contact Lenses With Alternative Lidstock

Conditions
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Ocular Physiology

Intervention / Treatment
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* Device: Acuvue Oasys 1 Day for Astigmatism with Legacy lidstock
* Device: Acuvue Oasys 1 Day for Astigmatism with Amcor laminated lidstock


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potential subjects must satisfy all of 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. Habitually wear soft contact lenses (either sphere or toric) in both eyes in a daily reusable or daily disposable wear modality (i.e., not extended wear modality). Habitual wear 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. Have the spherical component of their vertex-corrected distance refraction within the range +4.00 to -9.00 DS (inclusive) in both eyes. Have the magnitude of the cylindrical component of their vertex-corrected distance refraction below 3.00 DC (inclusive) in both eyes. Have best corrected monocular distance VA 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: The subject must not: Be currently pregnant or lactating. Be diabetic. Be currently using any ocular medications or have an ocular infection of any type. Have any ocular or systemic allergies, disease, infection, or use of medication that might contraindicate or interfere with contact lens wear or otherwise compromise study endpoints, including infectious diseases (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), or history of serious mental illness or seizures. See section 9.1 for additional details regarding systemic medications. 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 or 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 family member of an employee of investigational clinic. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment. Have clinically significant (Grade 3 or 4 on the FDA classification scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that may contraindicate contact lens wear or otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). Have fluctuations in vision due to clinically significant dry eye or other ocular conditions. Have had or have planned (within the study period) ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test/Control<br>Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to wear two different study lenses, one at a time, over two wear periods (test then control) with a washout period of 15 minutes between wears. During each wear period the lenses will be worn bilaterally for at least one hour in-office. | Device: Acuvue Oasys 1 Day for Astigmatism with Legacy lidstock<br>* CONTROL<br>Device: Acuvue Oasys 1 Day for Astigmatism with Amcor laminated lidstock<br>* TEST<br>|
| Experimental: Control/Test<br>Eligible subjects who are habitual soft contact lens wearers will be randomized into the Control/Test sequence, to wear two different study lenses, one at a time, over two wear periods (control then test) with a washout period of 15 minutes between wears. During each wear period the lenses will be worn bilaterally for at least one hour in-office. | Device: Acuvue Oasys 1 Day for Astigmatism with Legacy lidstock<br>* CONTROL<br>Device: Acuvue Oasys 1 Day for Astigmatism with Amcor laminated lidstock<br>* TEST<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of eyes with 'moderate' or 'severe' subject-reported ocular symptoms | Frequency and severity by eye of subject-reported ocular symptoms and problems with the study lens following lens settling and again following at least 1 hour of bilateral study lens wear. Severity of the symptoms can be: 0 = Not Applicable or Not Recorded; = Mild and results in little or no interference with lens wear; = Moderate AND/OR occasionally interferes with lens wear; = Severe AND/OR frequently interferes with lens wear. | Up to 1 hour of lens wear |