Design Validation of Toric Contact Lenses in Senofilcon A With a Blue-Blocking Chromophore

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-treatment, 2-sequence, 2-period crossover study.

Official Title
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Design Validation of Toric Contact Lenses in Senofilcon A With a Blue-Blocking Chromophore

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: Acuvue Oasys 1 Day for Astigmatism
* Device: TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore


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 years of age (inclusive) at the time of screening. 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 (°) 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: 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. 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 who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to wear bilaterally two different study lenses, one at a time, for a minimum of 8 hours per day for at least 5 days during each wear period, over two wear periods (test then control) with a washout period of 7+/-2 days duration between wear periods. | Device: Acuvue Oasys 1 Day for Astigmatism<br>* CONTROL<br>Device: TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore<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 bilaterally two different study lenses, one at a time, for a minimum of 8 hours per day for at least 5 days during each wear period, over two wear periods (control then test) with a washout period of 7+/-2 days duration between wear periods. | Device: Acuvue Oasys 1 Day for Astigmatism<br>* CONTROL<br>Device: TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore<br>* TEST<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit Lamp Findings (SLF) | SLFs (Grade 3 or higher) related to study lens wear will be assessed for each eye at all study visits. SLFs will be evaluated and graded using the FDA Grading scale from 0 to 4, where Grade 0 represents the absence of findings and 1 to 4 representing successively worse findings. | At the 1 week follow up | 
| Acceptable Lens Fit | Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each subject eye. Lens fit will be deemed unacceptable if any one of the following criteria are met: limbal exposure at primary gaze or with extreme eye movement; edge lift; excessive movement in primary up gaze; insufficient movement in all three of the following conditions: primary gaze, up gaze, and push up test. | At the 1 week follow up | 
| Visual Acuity (logMAR) | Visual acuity (VA) will be measured monocularly at the 1-week follow-up evaluation under high-contrast (HLHC) (>400 lux, 120 - 200 cd/m2) conditions at a test distance of 4 meters. | At the 1 week follow up | 
| Toric Lens Orientation Absolute lens orientation | Toric lens orientation (scribe mark position relative to 6 o'clock) will be assessed for each eye at least 15 minutes after lens insertion. | 15 minutes after lens insertion | 
| Rotation Stability with blinks | Rotational stability with blinks will be assessed for each eye at least 15 minutes after lens insertion. | 15 minutes after lens insertion | 
| Subjective Vision | Subjective vision will be assessed using the Contact Lens User Experience (CLUE™) questionnaire after approximately 1 week of lens wear. 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. 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. A 5-point increase in an average CLUE™ score translates into 10% shift in the distribution of scores for population of soft contact lens. | At the 1 week follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CLUE Handling score | CLUE handling score will be assessed using the Contact Lens User Experience (CLUE™) questionnaire after approximately 1 week of lens wear. 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. 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. A 5-point increase in an average CLUE™ score translates into 10% shift in the distribution of scores for population of soft contact lens. | At the 1 week follow up | 
| CLUE Comfort score | CLUE comfort score will be assessed using the Contact Lens User Experience (CLUE™) questionnaire after approximately 1 week of lens wear. 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. 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. A 5-point increase in an average CLUE™ score translates into 10% shift in the distribution of scores for population of soft contact lens. | At the 1 week follow up |