Evaluation of ACUVUE OASYS® 1-Day for Astigmatism Lenses Produced on a New Manufacturing Line

Study Overview
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Brief Summary
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This is a bilateral, dispensing, randomized, controlled, double-masked, 2×2 cross-over study to evaluate the clinical performance of ACUVUE OASYS® 1-Day for Astigmatism contact lenses produced on a recently qualified manufacturing line.

Official Title
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Evaluation of ACUVUE OASYS® 1-Day for Astigmatism Lenses Produced on a New Manufacturing Line

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: ACUVUE OASYS® 1-Day for Astigmatism - TAM 24
* 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 all of the following criteria to be enrolled in the study: The subject must: 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 (inclusive) years of age at the time of screening. By self-report, habitually wear soft contact lenses 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 of wear per day, for a minimum of 2 days per week during the past month. Possess a wearable pair of spectacles that provide correction for distance vision. Have the spherical component of their vertex-corrected distance refraction must be between -0.875 to -4.625 DS (inclusive) in each eye. Have the magnitude of the cylindrical component of their vertex-corrected distance refraction between 0.625 DC and 1.625 DC in both eyes. Have the cylinder axis of their distance refraction between 165° and 15° (i.e., 180±15°, inclusive) or between 75° and 105° (i.e., 90±15°, inclusive) in each eye. 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: The subject must not: Be currently pregnant or lactating. Be diabetic. Be currently using any ocular medications or have any 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. Have clinically significant (grade 3 or higher on the FDA grading 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 contraindicate contact lens wear or may 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) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, 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 that are habitual contact lens wearers will be randomized into the (TEST/CONTROL) sequence and will wear two different study lenses one at a time over the two wear periods. During each wear period the lenses will be worn bilaterally for approximately 1 week. Study lenses will be worn for a minimum of 8 hours per day and at least 5 days per week during the wear period. | Device: ACUVUE OASYS® 1-Day for Astigmatism - TAM 24<br>* TEST<br>Device: ACUVUE OASYS® 1-Day for Astigmatism<br>* CONTROL<br>|
| Experimental: CONTROL/TEST<br>Eligible subjects that are habitual contact lens wearers will be randomized into the (CONTROL/TEST) sequence and will wear two different study lenses one at a time over the two wear periods. During each wear period the lenses will be worn bilaterally for approximately 1 week. Study lenses will be worn for a minimum of 8 hours per day and at least 5 days per week during the wear period. | Device: ACUVUE OASYS® 1-Day for Astigmatism - TAM 24<br>* TEST<br>Device: ACUVUE OASYS® 1-Day for Astigmatism<br>* CONTROL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CLUE Comfort Score | Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | Fitting, 1-Week Follow-up | 
| CLUE Vision Score | Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | Fitting, 1-Week Follow-up | 
| CLUE Handling Score | Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | Fitting, 1-Week Follow-up | 
| Monocular Visual Performance (LogMAR) | Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye. The average visual performance was reported for each lens type. | 1-Week Follow-up | 
| Lens Rotation | Lens rotation was recorded from direction and magnitude in degrees to the nearest degree at one and three minutes following lens insertion during settling period. All lenses in this study have scribe marks at 6 o'clock and 12 o'clock positions and rotation measurements were made relative to a vertical reference line. | Post-Fitting at 1-minute, at 3-minute | 
| Settled Rotation | Mean settled rotation was calculated from all repeated measures of signed lens orientation upon settling for each subject/eye/lens. | Fitting, 1-Week Follow-up |