Clinical Evaluation of Approved and Investigational Contact Lenses

Study Overview
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Brief Summary
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This study is a multi-site, 5-visit dispensing, bilateral double-arm parallel group design, double-masked clinical trial using an investigational contact lens and a marketed contact lens. The objective is to evaluate comfort of the contact lenses when worn on a daily wear modality.

Conditions
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Visual Disorder

Intervention / Treatment
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* Device: Investigational Contact Lenses (Test)
* Device: Marketed Contact Lenses (Control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. The subject must be between 18 to 40 years of age at the time of consent. The subject's vertexed spherical equivalent distance refraction must be in the range of +8.00 to -12.00 in each eye. Subject wears habitual contact lenses a minimum of 4 days per week, eight hours per day. The subject must have best corrected visual acuity of 20/30 or better in each eye. The subject must be a habitual frequent replacement daily wear spherical silicone hydrogel soft contact lens wearer in both eyes. The subject must be able to wear contact lenses for a minimum of 8 hours each day during the study. 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 ocular or systemic allergies or diseases that may interfere with contact lens wear. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution. 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 interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (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 ocular infection. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 (Test Lens)<br>Subjects will be dispensed the Investigational Contact Lenses (Test) to be worn as daily wear. | Device: Investigational Contact Lenses (Test)<br> <br> * Other names: senofilcon C;|
| Active Comparator: Arm 2 (Control Lens)<br>Subjects will be dispensed the Marketed Contact Lenses (Control) to be worn as daily wear. | Device: Marketed Contact Lenses (Control)<br> <br> * Other names: comfilcon A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptable Lens Fitting | Lens fit was assessed and recorded for each subject and eye at post lens fitting, 1-, 2-, 3- and 4- week follow-up evaluations. Lens fit was a binary response acceptable and unacceptable lens fit. The proportion of eyes with acceptable lens fitting at post lens fit and across all four follow-ups was combined and reported. | Up to 4 Week Follow-up | 
| Overall Comfort | Clue 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. CLUE Comfort was assessed at 1-, 2-, 3 and 4- week Follow-up evaluations. The average CLUE comfort score for each lens was reported for each visit. | Up to 4 Week Follow-up |