Clinical Evaluation of Two Silicone Hydrogel Daily Disposable Contact Lenses

Study Overview
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Brief Summary
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The purpose of this investigation is to evaluate the short-term, clinical performance of two silicone hydrogel daily disposable contact lenses.

Conditions
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Vision Disorders

Intervention / Treatment
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* Device: JJVC Marketed Contact Lens (Test)
* Device: Competitor Marketed Contact Lens (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 (and including) 18 and 39 years of age. The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day worn for at least 30 days immediately preceding the study. The subject must have vertex-corrected distance refraction that allows a plano over-refraction with the available contact lens powers of -0.50 to -6.00 Diopters (D) in each eye. The subject must have refractive astigmatism, if present, of less than or equal to 1.00 D in each eye. The subject must have best corrected visual acuity of 20/25 or better in each eye. Exclusion Criteria: Currently pregnant or breastfeeding (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 autoimmune disease or use of medication, which may interfere with contact lens wear. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia. 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. Monovision, multi-focal, toric, or extended wear contact lens correction. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. History of binocular vision abnormality or strabismus that is likely to affect successful contact lens wear. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.

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 |
| --- | --- |
| Active Comparator: Sequence 1: Test Control Test<br>Test/control/test using the Johnson & Johnson Vision Care (JJVC) Marketed contact lens (test) and the Competitor Marketed contact lens (control). Lenses will be worn as daily wear, daily disposable on both eyes for approximately one week each in between lenses for total study duration of approximately three weeks per subject. Subjects are required to wear the lenses at least five days for at least eight hours per day worn. | Device: JJVC Marketed Contact Lens (Test)<br> <br> * Other names: senofilcon A;Device: Competitor Marketed Contact Lens (Control)<br> <br> * Other names: delefilcon A;|
| Active Comparator: Sequence 2: Control Test Control<br>Control/test/control using the JJVC Marketed contact lens (test) and the Competitor Marketed contact lens (control). Lenses will be worn as daily wear, daily disposable on both eyes for approximately one week each for total study duration of approximately three weeks per subject. Subjects are required to wear the lenses at least five days for at least eight hours per day worn. | Device: JJVC Marketed Contact Lens (Test)<br> <br> * Other names: senofilcon A;Device: Competitor Marketed Contact Lens (Control)<br> <br> * Other names: delefilcon A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Comfort | 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. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 134+138+134=406 (Observations- 1 per subject per period, however 1 observation was not recorded) from period 1, 2 and 3 respectively. For the delefilcon A lens 138+134+138=410 from period 1, 2 and 3 respectively. | 1 Week |