Initial Evaluation of Investigational Lenses Manufactured on a New Production Line

Study Overview
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Brief Summary
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This study is a randomized, 4-visit, subject-masked, 2x3 bilateral crossover, dispensing trial. Each study lens will be worn bilaterally in a daily wear (DW) modality for at least 6 hours per day and 5 days per week for approximately two weeks each. The subject will wear either the Test or Control lens twice and the other study lens once.

Official Title
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Initial Evaluation of Investigational Lenses Manufactured on a New Production Line

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: CONTROL Lens
* Device: TEST Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must read and sign the Informed Consent form. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. Healthy adult males or females age ≥18 and ≤49 years of age with signed informed consent. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and -6.00 D. The subject's refractive cylinder must be ≤ 1.00 D in each eye. The subject must have visual acuity best correctable to 20/25+3 or better for each eye. Subjects must own a wearable pair of spectacles. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of DW per day, at least 5 days per week, for a minimum of 1 month prior to the study) and willing to wear the study lenses on a similar basis. Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week. The subject must have normal eyes (i.e., no ocular medications or infections of any type). Exclusion Criteria: Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis). Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g., Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol), systemic steroids, and any prescribed or over the counter (OTC) ocular medication. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), LASIK, etc.). Any Grade 3 or greater slit lamp findings (e.g.., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear. Any known hypersensitivity or allergic reaction to Optifree® PureMoist® multi-purpose care solution or Eye-Cept® rewetting drop solution. Any ocular infection, allergy or clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Toric, extended wear, monovision or multi-focal contact lens correction. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. Participation in clinical trials involving the Test lens within 3 months prior to study enrollment. History of binocular vision abnormality or strabismus. Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 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>Subjects that are 18 to 49 years of age and current spherical soft contact lens wears will be randomized into one of two lens wear sequences. Subjects will wear the Test and Control lenses for two weeks each with one of the study lenses being worn twice for a total of 6 weeks. | Device: CONTROL Lens<br>* Acuvue OASYS<br>Device: TEST Lens<br>* senofilcon A<br>|
| Experimental: CONTROL/TEST/TEST<br>Subjects that are 18 to 49 years of age and current spherical soft contact lens wears will be randomized into one of two lens wear sequences. Subjects will wear the Test and Control lenses for two weeks each with one of the study lenses being worn twice for a total of 6 weeks. | Device: CONTROL Lens<br>* Acuvue OASYS<br>Device: TEST Lens<br>* senofilcon A<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall 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. | 2-Week Follow-up | 
| Vision Satisfaction in Bright Lighting | Vision satisfaction in bright light was assessed using the individual item I was satisfied with the quality of my vision in bright lighting from the CLUE™ questionnaire. This item used the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. CLUE is the Contact Lens User Experience™ 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 Proportion of responses in each category were reported for each lens type. | 2-Week Follow-up | 
| Distance Monocular LogMAR Visual Acuity | Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart under high illumination low contrast (room illumination > 400 lux and chart luminance 120-200 cd/m2) and low illumination high contrast (room illumination <2.5 lux and chart luminance 2.0 - 5.0 cd/m2 at the 2-week follow-up for each subject eye. The average visual acuity for each lens was reported. | 2-Week Follow-up | 
| Contact Lens Fitting Acceptance Rate | Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at all study visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The percentage of eyes with acceptable lens fit was reported for each lens. | Up to 2-Week Follow-up | 
| Number of Grade 3 or Higher Slit Lamp Findings | Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher by lens was reported. | Up to 2-Week Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Quality of Vision Score | Overall quality of 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. | 2-Week Follow-up | 
| Overall Handling Scores | 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. | 2-Week Follow-up | 
| Overall Quality of Vision Indoors | Overall Quality of Vision Indoors was assessed using the individual item Overall Quality of Vision Indoors from questionnaire assessing contact lens performance. This item used the response scale, 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. The Proportion of responses in each category were reported for each lens type. | 2-Week Follow-up |