Clinical Evaluation of the Safety and Efficacy of FID 120947A

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft contact lens wearers of Japanese ethnicity.

Conditions
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Refractive Error

Intervention / Treatment
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* Device: FID 120947A contact lens disinfecting solution
* Device: Soft contact lenses (SCL)
* Device: SCL preservative solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Successful history of silicone hydrogel or other soft contact lens wear (except for daily disposable lenses) in both eyes during the past 3 months and history of at least 5 consecutive days of successful DAILY wear in both eyes at Visit 1; Best spectacle corrected distance visual acuity greater than or equal to 0.8 (decimal visual acuity) in each eye; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Any ocular or systemic medical condition that may, in the opinion of the Investigator, preclude safe administration of the investigational products or affect the results of this study; Need to wear contact lenses on an extended wear basis (ie, overnight) during the study; Monocular (only 1 eye with functional vision) or fit with only 1 lens; Use of a daily cleaner and/or enzyme cleaner to care for lenses at least 7 days prior to Visit 1 (use of lens rewetting drops is acceptable); History of intolerance or hypersensitivity to any component of the investigational products; Unwilling or unable to abstain from use of all over-the-counter (OTC) or prescribed topical ocular medications (except for rewetting drops) within 7 days prior to Visit 1 and for the duration of the study; Moderate (grade 3) or severe (grade 4) corneal edema, corneal staining, injection (limbal hyperemia, bulbar conjunctival hyperemia), tarsal abnormalities, or other findings; Corneal vascularization that is mild (grade 2) or higher; Conjunctival or structural lid abnormalities or abnormal corneal opacities at Visit 1; Current or history of ocular infection, severe inflammation or disease within 6 months prior to Visit 1; Any systemic disease (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions; Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1; Ocular or intra-ocular surgery and/or ocular trauma within the last 12 months (excluding placement of punctal plugs); Participation in any investigational clinical study within 30 days of Visit 1; Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FID 120947A<br>FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care. | Device: FID 120947A contact lens disinfecting solution<br>* Investigational 3% hydrogen peroxide solution that uses a platinum catalyst for neutralization and is intended for simultaneous cleaning, protein removal, disinfecting and storage of silicone hydrogel and soft contact lenses<br>* Other names: Clear Care® Plus;Device: Soft contact lenses (SCL)<br>* Commercially available soft contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (180 days). A fresh pair will be dispensed on Day 0, Day 30, Day 60, and Day 135.<br>* Other names: 2-Week Acuvue®;Device: SCL preservative solution<br>* Commercially available solution for rinsing soft contact lenses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Eyes With Visibly Clean Lenses at Each Visit | Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. Both eyes contributed to the analysis. | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 
| Number of Eyes With Film Deposits on Lens by Type at Each Visit | Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Both eyes contributed to the analysis. | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 
| Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Both eyes contributed to the analysis. | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 
| Percentage of Lens Area Covered by Film Deposits at Each Visit | Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. For each visit, the number analyzed represents the number of eyes with film deposits on lens, respectively. | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 
| Percentage of Lens Area Covered by Crystalline Deposits at Each Visit | Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. For each visit, the number analyzed represents the number of eyes with film deposits on lens, respectively. | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 
| Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using Decimal acuity, where 1.0 (equivalent to 20/20) is considered normal distance-eyesight. A line increase indicates an improvement in VA. Both eyes contributed to the analysis | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 
| Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit | Subject recorded a response to the question, Averaging over the last 3 days, how many hours per day did you wear your contact lenses? Lens wear time was summarized as an estimate of the subject's daily wear, averaged over the course of 3 days prior to each scheduled visit, and measured in hours. Habitual lenses were used at the Day 0 time point. | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 
| Lens Wear Time at Each Visit Day | Subject recorded a response to the question, How many hours have you worn your contact lenses today? Lens wear was measured in hours. Habitual lenses were used at the Day 0 time point. | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 
| Average Rewetting Drop Frequency at Each Visit | Subject recorded a response to the question, Averaging over the last 3 days, how many times per day did you use rewetting drops? Habitual lenses were used at the Day 0 time point. | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 
| Number of Unscheduled Lens Replacements by Reason | Subjects were dispensed enough contact lenses to follow a 2-week replacement schedule during the study. Lenses replaced at other times were considered unscheduled. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject. All lenses which were replaced are counted. Habitual lenses were used at the Day 0 time point. | Up to Day 180 | 
| Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects. Habitual lenses and habitual lens care solution were used at the Day 0 time point. | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 
| Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects. Habitual lenses and habitual lens care solution were used at the Day 0 time point. | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 
| Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects. Habitual lenses and habitual lens care solution were used at the Day 0 time point. | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 |