The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft contact lens wearers of Japanese ethnicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
91
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
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.
Commercially available solution for rinsing soft contact lenses
Contact Alcon Japan, Ltd. for Trial Locations
Tokyo, Japan
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180