Clinical Evaluation of Spherical Soft Contact Lenses, Toric Soft Contact Lenses and Spectacles in Low Astigmats

Study Overview
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Brief Summary
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This will be a 5-visit, randomized, partially single-masked, bilateral wear, dispensing, 2-treatment × 2-period crossover study with spectacle-wear washout and wash-in periods.

Official Title
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Clinical Evaluation of Spherical Soft Contact Lenses, Toric Soft Contact Lenses and Spectacles in Low Astigmats

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: ACUVUE Oasys 1-Day with HydraLuxe Technology for Astigmatism
* Device: ACUVUE Oasys 1-Day with HydraLuxe Technology


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 (inclusive) years of age at the time of screening. By self-report, habitually wear soft contact lenses (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 of wear per day, for a minimum of 2 days per week during the past 4 weeks. Possess a wearable pair of spectacles that provide correction for distance vision. In both eyes, have magnitude of the cylinder component of their vertex-corrected distance refraction greater than or equal to 0.625 DC and less than 1.625 DC. In both eyes, have the mean sphere of their vertex-corrected distance refraction minus half of the indicated contact lens label cylinder power be between -0.875 to -4.625 DS (inclusive). For each eye, 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). For both eyes, have the sphere power of their habitual spectacles within ±0.50 Diopters Sphere (DS) (inclusive) of the sphere power of their current subjective refraction. For both eyes, have the cylinder power of their habitual spectacles within ±0.50 Diopters Cylinder (DC) (inclusive) of the cylinder power of their current subjective refraction. For both eyes, have the cylinder axis of their habitual spectacles within ±20° (inclusive) of the cylinder axis of their current subjective refraction. Achieve monocular VA of 20/30 or better with their habitual spectacles in both eyes. 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 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. See section 9.1 for additional details regarding excluded 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. 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test/Control<br>Eligible subjects will be randomized to the sequence, Test/Control | Device: ACUVUE Oasys 1-Day with HydraLuxe Technology for Astigmatism<br>* TEST<br>Device: ACUVUE Oasys 1-Day with HydraLuxe Technology<br>* CONTROL<br>|
| Experimental: Control/Test<br>Eligible subjects will be randomized to the sequence, Control/Test | Device: ACUVUE Oasys 1-Day with HydraLuxe Technology for Astigmatism<br>* TEST<br>Device: ACUVUE Oasys 1-Day with HydraLuxe Technology<br>* CONTROL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Luminance High Contrast Monocular Visual Acuity (LogMAR) | Visual Acuity was collected for each subject eye at distance (4 meter) 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. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. Lower values of visual acuity indicate better vision. The average logMAR Visual Acuity was reported for each lens type. | 1-Week Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CLUE Vision Score | CLUE Vision Score 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. The average CLUE vision score for each lens type was reported. | 1-Week Follow-up | 
| High Luminance High Contrast Monocular Visual Acuity (LogMAR) | Visual Acuity was collected for each subject eye at distance (4 meter) 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. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. Lower values of visual acuity indicate better vision. The average logMAR Visual Acuity was reported for each lens type. Data summaries for the Control lens are reported for the first primary measure outcome. | 1-Week Follow-up | 
| Subjective Contact Lens Preference |  | 1-Week Follow-up |