Myopia, Astigmatism, Hyperopia, Refractive Error
Conditions
Keywords
contact lenses, contact lens solution, gas permeable contact lenses
Brief summary
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
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).
Interventions
Investigational 3% hydrogen peroxide solution intended for simultaneous cleaning, protein removal, disinfecting and storage of gas permeable contact lenses
DEVICEBoston Simplus multi-action solution
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
DEVICEGas 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).
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Visibly Clean Lenses | Day 7, Day 30, Day 60, Day 90 | 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. |
| Percentage of Subjects With Crystalline Deposits by Type | Day 7, Day 30, Day 60, Day 90 | 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. |
| Percentage of Subjects With Film Deposits by Type | Day 7, Day 30, Day 60, Day 90 | 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. |
| Average Residual Lens Lysozyme | Day 90/Early Exit | 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. |
| Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Baseline (Day 0), Day 7, Day 30, Day 60, Day 90 | 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. |
| Average Lens Wear Time | Day 7, Day 30, Day 60, Day 90 | 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. |
| Number of Unscheduled Lens Replacements by Reason | Up to Day 90 | 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. |
| Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 7, Day 30, Day 60, Day 90 | 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. |
| Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 7, Day 30, Day 60, Day 90 | 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. |
| Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 7, Day 30, Day 60, Day 90 | 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. |
| Crystalline Deposit Area Covered | Day 7, Day 30, Day 60, Day 90 | 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. |
| Film Deposit Area Covered | Day 7, Day 30, Day 60, Day 90 | 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. |
Participant flow
Recruitment details
Subjects were recruited from 12 study centers located in the US.
Pre-assignment details
Of the 112 enrolled, 2 subjects were exited as screen failures and 4 were discontinued prior to randomization. This reporting group includes all randomized subjects (106).
Participants by arm
| Arm | Count |
|---|---|
| FID 120974A Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days | 71 |
| Boston Simplus Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days | 35 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | FID 120974A | Boston Simplus | Total |
|---|---|---|---|
| Age, Continuous | 52.9 years STANDARD_DEVIATION 10.2 | 50.5 years STANDARD_DEVIATION 13.4 | 52.1 years STANDARD_DEVIATION 11.4 |
| Sex: Female, Male Female | 55 Participants | 28 Participants | 83 Participants |
| Sex: Female, Male Male | 16 Participants | 7 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 112 | 0 / 71 | 0 / 35 |
| serious Total, serious adverse events | 0 / 112 | 0 / 71 | 0 / 35 |
Outcome results
Primary
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
Population: This analysis population includes all subjects with data at visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FID 120974A | Average Lens Wear Time | Day 7 | 12.3 Hours | Standard Deviation 2.7 |
| FID 120974A | Average Lens Wear Time | Day 60 | 11.8 Hours | Standard Deviation 2.9 |
| FID 120974A | Average Lens Wear Time | Day 90 | 12.4 Hours | Standard Deviation 2.8 |
| FID 120974A | Average Lens Wear Time | Day 30 | 12.5 Hours | Standard Deviation 2.7 |
| Boston Simplus | Average Lens Wear Time | Day 90 | 13.1 Hours | Standard Deviation 2.6 |
| Boston Simplus | Average Lens Wear Time | Day 7 | 13.3 Hours | Standard Deviation 2.4 |
| Boston Simplus | Average Lens Wear Time | Day 30 | 12.7 Hours | Standard Deviation 2.8 |
| Boston Simplus | Average Lens Wear Time | Day 60 | 13.3 Hours | Standard Deviation 2.6 |
Primary
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.
Time frame: Day 90/Early Exit
Population: This analysis population includes all randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FID 120974A | Average Residual Lens Lysozyme | 0.2 micrograms per lens | Standard Deviation 0.5 |
| Boston Simplus | Average Residual Lens Lysozyme | 0.2 micrograms per lens | Standard Deviation 0.4 |
Primary
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
Population: This analysis population includes all randomized subjects. Here, n is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FID 120974A | Crystalline Deposit Area Covered | Day 7, n=10, 5 | 18.0 percentage of lens area | Standard Deviation 16.2 |
| FID 120974A | Crystalline Deposit Area Covered | Day 30, n=17, 3 | 13.6 percentage of lens area | Standard Deviation 18.1 |
| FID 120974A | Crystalline Deposit Area Covered | Day 60, n=18, 8 | 11.9 percentage of lens area | Standard Deviation 14.1 |
| FID 120974A | Crystalline Deposit Area Covered | Day 90, n=21, 10 | 18.1 percentage of lens area | Standard Deviation 16.3 |
| Boston Simplus | Crystalline Deposit Area Covered | Day 90, n=21, 10 | 10.8 percentage of lens area | Standard Deviation 14.5 |
| Boston Simplus | Crystalline Deposit Area Covered | Day 7, n=10, 5 | 19.0 percentage of lens area | Standard Deviation 18.2 |
| Boston Simplus | Crystalline Deposit Area Covered | Day 60, n=18, 8 | 7.0 percentage of lens area | Standard Deviation 3.5 |
| Boston Simplus | Crystalline Deposit Area Covered | Day 30, n=17, 3 | 16.7 percentage of lens area | Standard Deviation 20.2 |
Primary
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
Population: This analysis population includes all randomized subjects. Here, n is the total number of subjects with film deposits in each treatment group, respectively, by visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FID 120974A | Film Deposit Area Covered | Day 7, n=40, 15 | 23.8 percentage of lens area | Standard Deviation 17.2 |
| FID 120974A | Film Deposit Area Covered | Day 30, n=47, 20 | 26.2 percentage of lens area | Standard Deviation 22 |
| FID 120974A | Film Deposit Area Covered | Day 60, n=47, 20 | 26.4 percentage of lens area | Standard Deviation 17.5 |
| FID 120974A | Film Deposit Area Covered | Day 90, n=45, 24 | 25.3 percentage of lens area | Standard Deviation 13.7 |
| Boston Simplus | Film Deposit Area Covered | Day 90, n=45, 24 | 28.3 percentage of lens area | Standard Deviation 21.9 |
| Boston Simplus | Film Deposit Area Covered | Day 7, n=40, 15 | 22.7 percentage of lens area | Standard Deviation 13.7 |
| Boston Simplus | Film Deposit Area Covered | Day 60, n=47, 20 | 24.0 percentage of lens area | Standard Deviation 11 |
| Boston Simplus | Film Deposit Area Covered | Day 30, n=47, 20 | 28.4 percentage of lens area | Standard Deviation 21.1 |
Primary
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
Population: This analysis population includes all subjects with data at visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 7, Strongly Agree | 37.7 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 7, Agree | 40.6 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 7, Undecided | 2.9 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 7, Disagree | 15.9 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 7, Strongly Disagree | 2.9 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 30, Strongly Agree | 29.0 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 30, Agree | 53.6 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 30, Undecided | 7.2 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 30, Disagree | 10.1 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 30, Strongly Disagree | 0.0 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 60, Strongly Agree | 33.3 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 60, Agree | 49.3 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 60, Undecided | 4.3 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 60, Disagree | 11.6 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 60, Strongly Disagree | 1.4 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 90, Strongly Agree | 29.0 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 90, Agree | 49.3 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 90, Undecided | 7.2 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 90, Disagree | 13.0 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 90, Strongly Disagree | 1.4 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 90, Undecided | 5.7 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 7, Strongly Agree | 48.6 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 60, Strongly Agree | 57.1 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 7, Agree | 45.7 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 90, Strongly Agree | 45.7 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 7, Undecided | 0.0 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 60, Agree | 28.6 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 7, Disagree | 5.7 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 90, Strongly Disagree | 0.0 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 7, Strongly Disagree | 0.0 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 60, Undecided | 5.7 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 30, Strongly Agree | 48.6 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 90, Agree | 34.3 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 30, Agree | 45.7 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 60, Disagree | 8.6 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 30, Undecided | 2.9 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 90, Disagree | 14.3 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 30, Disagree | 2.9 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 60, Strongly Disagree | 0.0 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 30, Strongly Disagree | 0.0 percentage of subjects |
Primary
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
Population: This analysis population includes all subjects with data at visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 7, Strongly Agree | 23.2 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 7, Agree | 50.7 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 7, Undecided | 20.3 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 7, Disagree | 5.8 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 7, Strongly Disagree | 0.0 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 30, Strongly Agree | 26.1 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 30, Agree | 53.6 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 30, Undecided | 13.0 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 30, Disagree | 5.8 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 30, Strongly Disagree | 1.4 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 60, Strongly Agree | 26.1 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 60, Agree | 56.5 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 60, Undecided | 14.5 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 60, Disagree | 2.9 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 60, Strongly Disagree | 0.0 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 90, Strongly Agree | 27.5 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 90, Agree | 52.2 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 90, Undecided | 11.6 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 90, Disagree | 7.2 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 90, Strongly Disagree | 1.4 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 90, Undecided | 5.7 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 7, Strongly Agree | 48.6 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 60, Strongly Agree | 51.4 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 7, Agree | 40.0 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 90, Strongly Agree | 48.6 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 7, Undecided | 8.6 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 60, Agree | 34.3 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 7, Disagree | 2.9 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 90, Strongly Disagree | 2.9 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 7, Strongly Disagree | 0.0 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 60, Undecided | 11.4 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 30, Strongly Agree | 57.1 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 90, Agree | 40.0 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 30, Agree | 34.3 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 60, Disagree | 0.0 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 30, Undecided | 8.6 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 90, Disagree | 2.9 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 30, Disagree | 0.0 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 60, Strongly Disagree | 2.9 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 30, Strongly Disagree | 0.0 percentage of subjects |
Primary
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
Population: This analysis population includes all subjects with data at visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 7, Strongly Agree | 30.4 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 7, Agree | 52.2 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 7, Undecided | 7.2 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 7, Disagree | 10.1 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 7, Strongly Disgree | 0.0 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 30, Strongly Agree | 31.9 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 30, Agree | 47.8 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 30, Undecided | 4.3 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 30, Disagree | 13.0 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 30, Strongly Disagree | 2.9 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 60, Strongly Agree | 30.4 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 60, Agree | 49.3 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 60, Undecided | 8.7 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 60, Disagree | 10.1 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 60, Strongly Disagree | 1.4 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 90, Strongly Agree | 30.4 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 90, Agree | 50.7 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 90, Undecided | 1.4 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 90, Disagree | 15.9 percentage of subjects |
| FID 120974A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 90, Strongly Disagree | 1.4 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 90, Undecided | 2.9 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 7, Strongly Agree | 68.6 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 60, Strongly Agree | 62.9 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 7, Agree | 28.6 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 90, Strongly Agree | 54.3 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 7, Undecided | 0.0 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 60, Agree | 28.6 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 7, Disagree | 2.9 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 90, Strongly Disagree | 2.9 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 7, Strongly Disgree | 0.0 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 60, Undecided | 0.0 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 30, Strongly Agree | 68.6 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 90, Agree | 28.6 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 30, Agree | 28.6 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 60, Disagree | 5.7 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 30, Undecided | 2.9 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 90, Disagree | 11.4 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 30, Disagree | 0.0 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 60, Strongly Disagree | 2.9 percentage of subjects |
| Boston Simplus | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 30, Strongly Disagree | 0.0 percentage of subjects |
Primary
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
Population: This analysis population includes all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FID 120974A | Number of Unscheduled Lens Replacements by Reason | Lost | 3 lenses |
| FID 120974A | Number of Unscheduled Lens Replacements by Reason | Lens torn on eye | 0 lenses |
| FID 120974A | Number of Unscheduled Lens Replacements by Reason | Lens torn while handling | 1 lenses |
| Boston Simplus | Number of Unscheduled Lens Replacements by Reason | Lost | 1 lenses |
| Boston Simplus | Number of Unscheduled Lens Replacements by Reason | Lens torn on eye | 1 lenses |
| Boston Simplus | Number of Unscheduled Lens Replacements by Reason | Lens torn while handling | 0 lenses |
Primary
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
Population: This analysis population includes all subjects with data at visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 7, 2 Line Increase from Baseline | 0.0 percentage of subjects |
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 7, 1 Line Increase from Baseline | 2.9 percentage of subjects |
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 7, No Change from Baseline | 92.8 percentage of subjects |
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 7, 1 Line Decrease from Baseline | 4.3 percentage of subjects |
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 7, 2 Line Decrease from Baseline | 0.0 percentage of subjects |
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 30, 2 Line Increase from Baseline | 0.0 percentage of subjects |
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 30, 1 Line Increase from Baseline | 1.4 percentage of subjects |
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 30, No Change from Baseline | 95.7 percentage of subjects |
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 30, 1 Line Decrease from Baseline | 2.9 percentage of subjects |
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 30, 2 Line Decrease from Baseline | 0.0 percentage of subjects |
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 60, 2 Line Increase from Baseline | 1.4 percentage of subjects |
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 60, 1 Line Increase from Baseline | 1.4 percentage of subjects |
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 60, No Change from Baseline | 97.1 percentage of subjects |
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 60, 1 Line Decrease from Baseline | 0.0 percentage of subjects |
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 60, 2 Line Decrease from Baseline | 0.0 percentage of subjects |
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 90, 2 Line Increase from Baseline | 0.0 percentage of subjects |
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 90, 1 Line Increase from Baseline | 0.0 percentage of subjects |
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 90, No Change from Baseline | 97.1 percentage of subjects |
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 90, 1 Line Decrease from Baseline | 2.9 percentage of subjects |
| FID 120974A | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 90, 2 Line Decrease from Baseline | 0.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 90, No Change from Baseline | 91.4 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 7, 2 Line Increase from Baseline | 0.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 60, 2 Line Increase from Baseline | 0.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 7, 1 Line Increase from Baseline | 0.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 90, 2 Line Increase from Baseline | 2.9 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 7, No Change from Baseline | 94.3 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 60, 1 Line Increase from Baseline | 2.9 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 7, 1 Line Decrease from Baseline | 5.7 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 90, 2 Line Decrease from Baseline | 0.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 7, 2 Line Decrease from Baseline | 0.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 60, No Change from Baseline | 94.3 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 30, 2 Line Increase from Baseline | 0.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 90, 1 Line Increase from Baseline | 2.9 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 30, 1 Line Increase from Baseline | 0.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 60, 1 Line Decrease from Baseline | 2.9 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 30, No Change from Baseline | 97.1 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 90, 1 Line Decrease from Baseline | 2.9 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 30, 1 Line Decrease from Baseline | 2.9 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 60, 2 Line Decrease from Baseline | 0.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Day 30, 2 Line Decrease from Baseline | 0.0 percentage of subjects |
Primary
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
Population: This analysis population includes all randomized subjects. Here, n is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FID 120974A | Percentage of Subjects With Crystalline Deposits by Type | Day 7, Type II, n=10, 5 | 90.0 percentage of subjects |
| FID 120974A | Percentage of Subjects With Crystalline Deposits by Type | Day 7, Type III, n=10, 5 | 0.0 percentage of subjects |
| FID 120974A | Percentage of Subjects With Crystalline Deposits by Type | Day 7, Type IV, n=10, 5 | 10.0 percentage of subjects |
| FID 120974A | Percentage of Subjects With Crystalline Deposits by Type | Day 30, Type II, n=17, 3 | 70.6 percentage of subjects |
| FID 120974A | Percentage of Subjects With Crystalline Deposits by Type | Day 30, Type III, n=17, 3 | 17.6 percentage of subjects |
| FID 120974A | Percentage of Subjects With Crystalline Deposits by Type | Day 30, Type IV, n=17, 3 | 11.8 percentage of subjects |
| FID 120974A | Percentage of Subjects With Crystalline Deposits by Type | Day 60, Type II, n=18, 8 | 61.1 percentage of subjects |
| FID 120974A | Percentage of Subjects With Crystalline Deposits by Type | Day 60, Type III, n=18, 8 | 16.7 percentage of subjects |
| FID 120974A | Percentage of Subjects With Crystalline Deposits by Type | Day 60, Type IV, n=18, 8 | 22.2 percentage of subjects |
| FID 120974A | Percentage of Subjects With Crystalline Deposits by Type | Day 90, Type II, n=21, 10 | 61.9 percentage of subjects |
| FID 120974A | Percentage of Subjects With Crystalline Deposits by Type | Day 90, Type III, n=21, 10 | 23.8 percentage of subjects |
| FID 120974A | Percentage of Subjects With Crystalline Deposits by Type | Day 90, Type IV, n=21, 10 | 14.3 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Crystalline Deposits by Type | Day 90, Type III, n=21, 10 | 10.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Crystalline Deposits by Type | Day 7, Type II, n=10, 5 | 80.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Crystalline Deposits by Type | Day 60, Type II, n=18, 8 | 87.5 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Crystalline Deposits by Type | Day 7, Type III, n=10, 5 | 20.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Crystalline Deposits by Type | Day 90, Type II, n=21, 10 | 60.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Crystalline Deposits by Type | Day 7, Type IV, n=10, 5 | 0.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Crystalline Deposits by Type | Day 60, Type III, n=18, 8 | 0.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Crystalline Deposits by Type | Day 30, Type II, n=17, 3 | 100.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Crystalline Deposits by Type | Day 90, Type IV, n=21, 10 | 30.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Crystalline Deposits by Type | Day 30, Type III, n=17, 3 | 0.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Crystalline Deposits by Type | Day 60, Type IV, n=18, 8 | 12.5 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Crystalline Deposits by Type | Day 30, Type IV, n=17, 3 | 0.0 percentage of subjects |
Primary
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
Population: This analysis population includes all randomized subjects. Here, n is the total number of subjects with film deposits in each treatment group, respectively, by visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FID 120974A | Percentage of Subjects With Film Deposits by Type | Day 7, Type II, n=40, 15 | 80.0 percentage of subjects |
| FID 120974A | Percentage of Subjects With Film Deposits by Type | Day 7, Type III, n=40, 15 | 7.5 percentage of subjects |
| FID 120974A | Percentage of Subjects With Film Deposits by Type | Day 7, Type IV, n=40, 15 | 12.5 percentage of subjects |
| FID 120974A | Percentage of Subjects With Film Deposits by Type | Day 30, Type II, n=47, 20 | 72.3 percentage of subjects |
| FID 120974A | Percentage of Subjects With Film Deposits by Type | Day 30, Type III, n=47, 20 | 10.6 percentage of subjects |
| FID 120974A | Percentage of Subjects With Film Deposits by Type | Day 30, Type IV, n=47, 20 | 17.0 percentage of subjects |
| FID 120974A | Percentage of Subjects With Film Deposits by Type | Day 60, Type II, n=47, 20 | 74.5 percentage of subjects |
| FID 120974A | Percentage of Subjects With Film Deposits by Type | Day 60, Type III, n=47, 20 | 21.3 percentage of subjects |
| FID 120974A | Percentage of Subjects With Film Deposits by Type | Day 60, Type IV, n=47, 20 | 4.3 percentage of subjects |
| FID 120974A | Percentage of Subjects With Film Deposits by Type | Day 90, Type II, n=45, 24 | 73.3 percentage of subjects |
| FID 120974A | Percentage of Subjects With Film Deposits by Type | Day 90, Type III, n=45, 24 | 13.3 percentage of subjects |
| FID 120974A | Percentage of Subjects With Film Deposits by Type | Day 90, Type IV, n=45, 24 | 13.3 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Film Deposits by Type | Day 90, Type III, n=45, 24 | 8.3 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Film Deposits by Type | Day 7, Type II, n=40, 15 | 66.7 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Film Deposits by Type | Day 60, Type II, n=47, 20 | 80.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Film Deposits by Type | Day 7, Type III, n=40, 15 | 26.7 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Film Deposits by Type | Day 90, Type II, n=45, 24 | 79.2 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Film Deposits by Type | Day 7, Type IV, n=40, 15 | 6.7 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Film Deposits by Type | Day 60, Type III, n=47, 20 | 5.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Film Deposits by Type | Day 30, Type II, n=47, 20 | 80.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Film Deposits by Type | Day 90, Type IV, n=45, 24 | 12.5 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Film Deposits by Type | Day 30, Type III, n=47, 20 | 10.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Film Deposits by Type | Day 60, Type IV, n=47, 20 | 15.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Film Deposits by Type | Day 30, Type IV, n=47, 20 | 10.0 percentage of subjects |
Primary
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
Population: This analysis population includes all subjects with data at visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FID 120974A | Percentage of Subjects With Visibly Clean Lenses | Day 30 | 29.0 percentage of subjects |
| FID 120974A | Percentage of Subjects With Visibly Clean Lenses | Day 60 | 29.0 percentage of subjects |
| FID 120974A | Percentage of Subjects With Visibly Clean Lenses | Day 90 | 30.4 percentage of subjects |
| FID 120974A | Percentage of Subjects With Visibly Clean Lenses | Day 7 | 42.0 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Visibly Clean Lenses | Day 90 | 31.4 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Visibly Clean Lenses | Day 60 | 42.9 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Visibly Clean Lenses | Day 7 | 57.1 percentage of subjects |
| Boston Simplus | Percentage of Subjects With Visibly Clean Lenses | Day 30 | 42.9 percentage of subjects |