Clinical Evaluation of Lapsed Contact Lens Wearers Who Are Re-fit Into Senofilcon A Contact Lenses

Study Overview
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Brief Summary
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This study is an open-label, multi-site study. The total number of subjects was 200. The duration of this study was approximately four weeks. The primary objective was to assess what percentage of lapsed contact wearers, who have discontinued use of their contact lenses for greater than six months can be successfully re-fit with senofilcon A, reusable 2-weekly replacement daily wear lenses (spherical and toric designs).

Official Title
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A Multi-Center Clinical Evaluation of Lapsed Contact Lens Wearers Who Are Re-Fit Into Spherical or Toric Senofilcon A Contact Lenses

Conditions
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Lapsed Contact Lens Wear

Intervention / Treatment
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* Device: senofilcon A
* Device: senofilcon A for Astigmatism


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 interested in wearing contact lenses. The subject must be at least 18 years old or less than 40 years of age at the time of consent. The subject's vertexed spherical cylindrical refraction must result in a contact lens prescription for each eye that is available in the investigator's choice of study contact lens material(s). The subject must have best corrected visual acuity of 20/30 or better in each eye. The subject must require visual correction in both eyes. The subject must be a lapsed wearer (defined as, any non-contact lens wearer requiring optical correction who has been previously fitted in and has previously purchased contact lenses but has since discontinued contact lens wear for any reason more than 6 months prior to the time of consent). 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. 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 tha 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 trial within one year prior to study enrollment. History of binocular vision abnormality or strabismus. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g., HIV), by self report. Employee of the investigational clinic (i.e., Investigator, Coordinator, or Technician).

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: senofilcon A<br>Contact lenses to be worn in a daily wear modality | Device: senofilcon A<br> <br> |
| Experimental: senofilcon A for Astigmatism<br>Contact lenses to be worn in a daily wear modality | Device: senofilcon A for Astigmatism<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Successfully Re-fitted Subjects | Percentage of lapsed contact wearers who were successfully refitted among subjects who have lapsed from contact lens use more than 6 months prior to the date of enrollment in the study. Successful fit was assessed by on eye care practitioner (ECP) judgment of acceptable physiology. | 4 weeks |