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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
112
Investigational 3% hydrogen peroxide solution intended for simultaneous cleaning, protein removal, disinfecting and storage of gas permeable contact lenses
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
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 7, Day 30, Day 60, Day 90