Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Gas Permeable Contact Lens Wearers

Study Overview
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Brief Summary
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The purpose of this study is demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in gas permeable lens wearers.

Detailed Description
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Subjects with normal eyes (other than correction for refractive error) successfully wearing silicone acrylate or fluoro silicone acrylate gas permeable contact lenses were randomized 2:1 to receive either the investigational or commercial contact lens solution for daily use throughout the study (90 days).

Official Title
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Clinical Evaluation of the Safety and Efficacy of FID 120947A Compared to a Marketed Lens Care Solution in Gas Permeable Contact Lens Wearers

Conditions
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Myopia, Astigmatism, Hyperopia, Refractive Error

Intervention / Treatment
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* Device: FID 120947A contact lens disinfecting solution
* Device: Boston Simplus multi-action solution
* Device: Gas permeable contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal eyes (other than correction for visual acuity); Successful history of gas permeable contact lens wear in both eyes in one of two brands: Boston XO or Boston II; Best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye; Other protocol-defined 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; Use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to Visit 1; History of intolerance or hypersensitivity to any component of the investigational products; Use of all over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1; Moderate, severe, abnormal, or other ocular findings; Current or history of ocular infection, severe inflammation, or disease within 6 months prior to Visit 1; Any systemic disease at Visit 1 (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; Ocular surgery within the last 12 months; Other protocol-defined exclusion criteria may apply.
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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FID 120974A<br>FID 120947A contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days | Device: FID 120947A contact lens disinfecting solution<br>* Investigational 3% hydrogen peroxide solution intended for simultaneous cleaning, protein removal, disinfecting and storage of gas permeable contact lenses<br>* Other names: Clear Care® Plus;Device: Gas permeable contact lenses<br>* Commercially available gas permeable contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (90 days).<br>* Other names: Boston II;|
| Active Comparator: Boston Simplus<br>Boston Simplus multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days | Device: Boston Simplus multi-action solution<br>* Commercially available solution indicated for cleaning, removing protein, rinsing, disinfecting, conditioning, storing and cushioning of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses<br>Device: Gas permeable contact lenses<br>* Commercially available gas permeable contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (90 days).<br>* Other names: Boston II;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Visibly Clean Lenses | 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. One eye (study eye) contributed to the analysis. | Day 7, Day 30, Day 60, Day 90 | 
| Percentage of Subjects With Crystalline Deposits by Type | 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: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis. | Day 7, Day 30, Day 60, Day 90 | 
| Percentage of Subjects With Film Deposits by Type | 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: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis. | Day 7, Day 30, Day 60, Day 90 | 
| Average Residual Lens Lysozyme | Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis. | Day 90/Early Exit | 
| Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis. | Baseline (Day 0), Day 7, Day 30, Day 60, Day 90 | 
| Average Lens Wear Time | 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 measured in hours. | Day 7, Day 30, Day 60, Day 90 | 
| Number of Unscheduled Lens Replacements by Reason | No lens replacements were planned during the study. Lenses could be replaced as needed due to loss, damage, or as deemed necessary by the Investigator. If it became necessary to replace a lens, the subject was examined at an unscheduled visit. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject. | Up to Day 90 | 
| 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. | Day 7, Day 30, Day 60, Day 90 | 
| 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. | Day 7, Day 30, Day 60, Day 90 | 
| 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. | Day 7, Day 30, Day 60, Day 90 | 
| Crystalline Deposit Area Covered | 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. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis. | Day 7, Day 30, Day 60, Day 90 | 
| Film Deposit Area Covered | 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. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis. | Day 7, Day 30, Day 60, Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact lenses, contact lens solution, gas permeable contact lenses