Refractive Error
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft contact lens wearers of Japanese ethnicity.
Interventions
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
DEVICESoft contact lenses (SCL)
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.
DEVICESCL preservative solution
Commercially available solution for rinsing soft contact lenses
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With Visibly Clean Lenses at Each Visit | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 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. |
| Number of Eyes With Film Deposits on Lens by Type at Each Visit | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 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. |
| Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 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. |
| Percentage of Lens Area Covered by Film Deposits at Each Visit | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 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. |
| Percentage of Lens Area Covered by Crystalline Deposits at Each Visit | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 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. |
| Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 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 |
| Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 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. |
| Lens Wear Time at Each Visit Day | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 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. |
| Average Rewetting Drop Frequency at Each Visit | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 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. |
| Number of Unscheduled Lens Replacements by Reason | Up to Day 180 | 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. |
| Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 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. |
| Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 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. |
| Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | 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. |
Countries
Japan
Participant flow
Recruitment details
Subjects were recruited from 6 study centers located in Japan.
Pre-assignment details
Of the 91 enrolled, 1 subject was exited as a screen failure prior to treatment. This reporting group includes all treated subjects (90).
Participants by arm
| Arm | Count |
|---|---|
| FID 120947A 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. | 90 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | FID 120947A |
|---|---|
| Age, Continuous | 32.1 years STANDARD_DEVIATION 9.05 |
| Sex: Female, Male Female | 69 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 180 |
| other Total, other adverse events | 0 / 90 | 25 / 180 |
| serious Total, serious adverse events | 0 / 90 | 0 / 180 |
Outcome results
Primary
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
Population: Full Analysis Set, with non-missing response
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FID 120947A | Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit | Day 0 | 12.4 hours | Standard Deviation 2.54 |
| FID 120947A | Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit | Day 7 | 11.9 hours | Standard Deviation 2.58 |
| FID 120947A | Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit | Day 30 | 12.0 hours | Standard Deviation 2.5 |
| FID 120947A | Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit | Day 60 | 11.8 hours | Standard Deviation 2.53 |
| FID 120947A | Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit | Day 90 | 11.7 hours | Standard Deviation 2.73 |
| FID 120947A | Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit | Day 135 | 11.9 hours | Standard Deviation 2.78 |
| FID 120947A | Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit | Day 180 | 11.8 hours | Standard Deviation 2.57 |
Primary
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
Population: Full Analysis Set, with non-missing response
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FID 120947A | Average Rewetting Drop Frequency at Each Visit | Day 0 | 0.3 times per day | Standard Deviation 1.11 |
| FID 120947A | Average Rewetting Drop Frequency at Each Visit | Day 7 | 1.4 times per day | Standard Deviation 2.27 |
| FID 120947A | Average Rewetting Drop Frequency at Each Visit | Day 30 | 1.7 times per day | Standard Deviation 1.85 |
| FID 120947A | Average Rewetting Drop Frequency at Each Visit | Day 60 | 1.6 times per day | Standard Deviation 1.79 |
| FID 120947A | Average Rewetting Drop Frequency at Each Visit | Day 90 | 1.7 times per day | Standard Deviation 1.93 |
| FID 120947A | Average Rewetting Drop Frequency at Each Visit | Day 135 | 1.8 times per day | Standard Deviation 1.97 |
| FID 120947A | Average Rewetting Drop Frequency at Each Visit | Day 180 | 1.7 times per day | Standard Deviation 2 |
Primary
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
Population: Full Analysis Set, with non-missing response
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FID 120947A | Lens Wear Time at Each Visit Day | Day 0 | 4.3 hours | Standard Deviation 3.53 |
| FID 120947A | Lens Wear Time at Each Visit Day | Day 7 | 4.8 hours | Standard Deviation 3.53 |
| FID 120947A | Lens Wear Time at Each Visit Day | Day 30 | 4.7 hours | Standard Deviation 3.27 |
| FID 120947A | Lens Wear Time at Each Visit Day | Day 60 | 4.2 hours | Standard Deviation 3.04 |
| FID 120947A | Lens Wear Time at Each Visit Day | Day 90 | 4.4 hours | Standard Deviation 3.33 |
| FID 120947A | Lens Wear Time at Each Visit Day | Day 135 | 4.4 hours | Standard Deviation 3.28 |
| FID 120947A | Lens Wear Time at Each Visit Day | Day 180 | 4.6 hours | Standard Deviation 3.35 |
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. 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
Population: Full Analysis Set with non-missing response
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FID 120947A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 0 | 42.2 percentage of subjects |
| FID 120947A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 180 | 44.2 percentage of subjects |
| FID 120947A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 135 | 41.2 percentage of subjects |
| FID 120947A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 30 | 46.1 percentage of subjects |
| FID 120947A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 7 | 48.9 percentage of subjects |
| FID 120947A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 60 | 42.7 percentage of subjects |
| FID 120947A | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 90 | 39.3 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 90 | 47.2 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 60 | 41.6 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 7 | 37.8 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 0 | 38.9 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 135 | 47.1 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 30 | 37.1 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 180 | 48.8 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 60 | 13.5 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 0 | 12.2 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 7 | 10.0 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 30 | 14.6 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 90 | 13.5 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 135 | 10.6 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 180 | 7.0 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 30 | 2.2 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 90 | 0.0 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 7 | 3.3 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 180 | 0.0 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 135 | 0.0 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 0 | 5.6 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 60 | 2.2 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 30 | 0.0 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 180 | 0.0 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 135 | 1.2 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 90 | 0.0 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 7 | 0.0 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 0 | 1.1 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear. | Day 60 | 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. 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
Population: Full Analysis Set with non-missing response
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FID 120947A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 0 | 44.4 percentage of subjects |
| FID 120947A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 60 | 25.8 percentage of subjects |
| FID 120947A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 30 | 31.5 percentage of subjects |
| FID 120947A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 180 | 34.9 percentage of subjects |
| FID 120947A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 135 | 29.4 percentage of subjects |
| FID 120947A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 90 | 30.3 percentage of subjects |
| FID 120947A | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 7 | 28.9 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 180 | 40.7 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 0 | 41.1 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 7 | 32.2 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 30 | 39.3 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 60 | 40.4 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 90 | 41.6 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 135 | 44.7 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 135 | 21.2 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 7 | 25.6 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 90 | 22.5 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 180 | 19.8 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 60 | 27.0 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 30 | 19.1 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 0 | 12.2 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 90 | 3.4 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 60 | 5.6 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 180 | 2.3 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 30 | 7.9 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 0 | 2.2 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 135 | 2.4 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 7 | 12.2 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 0 | 0.0 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 60 | 1.1 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 135 | 2.4 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 7 | 1.1 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 90 | 2.2 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 30 | 2.2 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling. | Day 180 | 2.3 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. 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
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FID 120947A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 0 | 26.7 percentage of subjects |
| FID 120947A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 180 | 41.9 percentage of subjects |
| FID 120947A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 135 | 38.8 percentage of subjects |
| FID 120947A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 30 | 29.2 percentage of subjects |
| FID 120947A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 7 | 35.6 percentage of subjects |
| FID 120947A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 60 | 34.8 percentage of subjects |
| FID 120947A | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 90 | 36.0 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 90 | 49.4 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 60 | 46.1 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 7 | 41.1 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 0 | 44.4 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 135 | 44.7 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 30 | 48.3 percentage of subjects |
| Type III | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 180 | 50.0 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 60 | 14.6 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 0 | 22.2 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 7 | 15.6 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 30 | 13.5 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 90 | 11.2 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 135 | 16.5 percentage of subjects |
| Type IV | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 180 | 8.1 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 30 | 9.0 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 90 | 2.2 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 7 | 7.8 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 180 | 0.0 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 135 | 0.0 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 0 | 6.7 percentage of subjects |
| No Change | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 60 | 4.5 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 30 | 0.0 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 180 | 0.0 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 135 | 0.0 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 90 | 1.1 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 7 | 0.0 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 0 | 0.0 percentage of subjects |
| 1 Line Decrease | Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day. | Day 60 | 0.0 percentage of subjects |
Primary
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
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FID 120947A | Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Day 7 | 4 eyes |
| FID 120947A | Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Day 30 | 5 eyes |
| FID 120947A | Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Day 60 | 0 eyes |
| FID 120947A | Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Day 90 | 1 eyes |
| FID 120947A | Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Day 135 | 0 eyes |
| FID 120947A | Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Day 180 | 0 eyes |
| Type III | Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Day 180 | 0 eyes |
| Type III | Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Day 7 | 8 eyes |
| Type III | Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Day 90 | 0 eyes |
| Type III | Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Day 135 | 0 eyes |
| Type III | Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Day 30 | 4 eyes |
| Type III | Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Day 60 | 0 eyes |
| Type IV | Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Day 30 | 8 eyes |
| Type IV | Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Day 60 | 4 eyes |
| Type IV | Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Day 180 | 5 eyes |
| Type IV | Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Day 90 | 10 eyes |
| Type IV | Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Day 7 | 2 eyes |
| Type IV | Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Day 135 | 3 eyes |
Primary
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
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FID 120947A | Number of Eyes With Film Deposits on Lens by Type at Each Visit | Day 7 | 0 eyes |
| FID 120947A | Number of Eyes With Film Deposits on Lens by Type at Each Visit | Day 30 | 3 eyes |
| FID 120947A | Number of Eyes With Film Deposits on Lens by Type at Each Visit | Day 60 | 1 eyes |
| FID 120947A | Number of Eyes With Film Deposits on Lens by Type at Each Visit | Day 90 | 1 eyes |
| FID 120947A | Number of Eyes With Film Deposits on Lens by Type at Each Visit | Day 135 | 2 eyes |
| FID 120947A | Number of Eyes With Film Deposits on Lens by Type at Each Visit | Day 180 | 1 eyes |
| Type III | Number of Eyes With Film Deposits on Lens by Type at Each Visit | Day 180 | 0 eyes |
| Type III | Number of Eyes With Film Deposits on Lens by Type at Each Visit | Day 7 | 3 eyes |
| Type III | Number of Eyes With Film Deposits on Lens by Type at Each Visit | Day 90 | 1 eyes |
| Type III | Number of Eyes With Film Deposits on Lens by Type at Each Visit | Day 135 | 1 eyes |
| Type III | Number of Eyes With Film Deposits on Lens by Type at Each Visit | Day 30 | 0 eyes |
| Type III | Number of Eyes With Film Deposits on Lens by Type at Each Visit | Day 60 | 0 eyes |
| Type IV | Number of Eyes With Film Deposits on Lens by Type at Each Visit | Day 30 | 4 eyes |
| Type IV | Number of Eyes With Film Deposits on Lens by Type at Each Visit | Day 60 | 3 eyes |
| Type IV | Number of Eyes With Film Deposits on Lens by Type at Each Visit | Day 180 | 1 eyes |
| Type IV | Number of Eyes With Film Deposits on Lens by Type at Each Visit | Day 90 | 2 eyes |
| Type IV | Number of Eyes With Film Deposits on Lens by Type at Each Visit | Day 7 | 1 eyes |
| Type IV | Number of Eyes With Film Deposits on Lens by Type at Each Visit | Day 135 | 2 eyes |
Primary
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
Population: Full Analysis Set, with specified reason for replacement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FID 120947A | Number of Unscheduled Lens Replacements by Reason | Unplanned - Lost | 7 lenses |
| FID 120947A | Number of Unscheduled Lens Replacements by Reason | Unplanned - Lens torn on eye | 5 lenses |
| FID 120947A | Number of Unscheduled Lens Replacements by Reason | Unplanned - Lens torn while handling | 38 lenses |
| FID 120947A | Number of Unscheduled Lens Replacements by Reason | Unplanned - Lens deposit | 17 lenses |
| FID 120947A | Number of Unscheduled Lens Replacements by Reason | Unplanned - Bad edge | 4 lenses |
| FID 120947A | Number of Unscheduled Lens Replacements by Reason | Unplanned - Bad surface | 0 lenses |
| FID 120947A | Number of Unscheduled Lens Replacements by Reason | Unplanned - Discoloration | 0 lenses |
| FID 120947A | Number of Unscheduled Lens Replacements by Reason | Unplanned - No lens in pack | 0 lenses |
| FID 120947A | Number of Unscheduled Lens Replacements by Reason | Unplanned - Visual Acuity | 2 lenses |
| FID 120947A | Number of Unscheduled Lens Replacements by Reason | Unplanned - Discomfort | 6 lenses |
| FID 120947A | Number of Unscheduled Lens Replacements by Reason | Unplanned - Pathology | 0 lenses |
| FID 120947A | Number of Unscheduled Lens Replacements by Reason | Other | 2 lenses |
Primary
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
Population: Full Analysis Set, with non-missing response
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FID 120947A | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 180 | 1.2 percentage of eyes |
| FID 120947A | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 90 | 0.0 percentage of eyes |
| FID 120947A | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 30 | 1.7 percentage of eyes |
| FID 120947A | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 135 | 1.8 percentage of eyes |
| FID 120947A | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 60 | 1.7 percentage of eyes |
| FID 120947A | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 7 | 0.6 percentage of eyes |
| Type III | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 180 | 2.3 percentage of eyes |
| Type III | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 7 | 0.6 percentage of eyes |
| Type III | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 135 | 3.0 percentage of eyes |
| Type III | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 60 | 3.4 percentage of eyes |
| Type III | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 90 | 3.4 percentage of eyes |
| Type III | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 30 | 3.4 percentage of eyes |
| Type IV | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 7 | 6.2 percentage of eyes |
| Type IV | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 180 | 9.9 percentage of eyes |
| Type IV | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 90 | 11.5 percentage of eyes |
| Type IV | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 30 | 7.3 percentage of eyes |
| Type IV | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 135 | 8.3 percentage of eyes |
| Type IV | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 60 | 10.7 percentage of eyes |
| No Change | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 180 | 75.6 percentage of eyes |
| No Change | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 7 | 90.4 percentage of eyes |
| No Change | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 30 | 84.8 percentage of eyes |
| No Change | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 60 | 79.2 percentage of eyes |
| No Change | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 90 | 79.9 percentage of eyes |
| No Change | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 135 | 77.4 percentage of eyes |
| 1 Line Decrease | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 30 | 2.8 percentage of eyes |
| 1 Line Decrease | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 60 | 3.9 percentage of eyes |
| 1 Line Decrease | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 7 | 1.7 percentage of eyes |
| 1 Line Decrease | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 135 | 8.9 percentage of eyes |
| 1 Line Decrease | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 90 | 4.6 percentage of eyes |
| 1 Line Decrease | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 180 | 8.1 percentage of eyes |
| 2 Line Decrease | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 30 | 0.0 percentage of eyes |
| 2 Line Decrease | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 7 | 0.6 percentage of eyes |
| 2 Line Decrease | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 180 | 1.7 percentage of eyes |
| 2 Line Decrease | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 90 | 0.6 percentage of eyes |
| 2 Line Decrease | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 60 | 1.1 percentage of eyes |
| 2 Line Decrease | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 135 | 0.6 percentage of eyes |
| ≥3 Line Decrease | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 60 | 0.0 percentage of eyes |
| ≥3 Line Decrease | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 180 | 1.2 percentage of eyes |
| ≥3 Line Decrease | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 30 | 0.0 percentage of eyes |
| ≥3 Line Decrease | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 90 | 0.0 percentage of eyes |
| ≥3 Line Decrease | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 135 | 0.0 percentage of eyes |
| ≥3 Line Decrease | Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Day 7 | 0.0 percentage of eyes |
Primary
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
Population: Full Analysis Set, with non-missing response
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FID 120947A | Percentage of Eyes With Visibly Clean Lenses at Each Visit | Day 7 | 92.2 percentage of eyes |
| FID 120947A | Percentage of Eyes With Visibly Clean Lenses at Each Visit | Day 30 | 88.2 percentage of eyes |
| FID 120947A | Percentage of Eyes With Visibly Clean Lenses at Each Visit | Day 60 | 95.5 percentage of eyes |
| FID 120947A | Percentage of Eyes With Visibly Clean Lenses at Each Visit | Day 90 | 92.5 percentage of eyes |
| FID 120947A | Percentage of Eyes With Visibly Clean Lenses at Each Visit | Day 135 | 95.2 percentage of eyes |
| FID 120947A | Percentage of Eyes With Visibly Clean Lenses at Each Visit | Day 180 | 95.9 percentage of eyes |
Primary
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.
Time frame: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FID 120947A | Percentage of Lens Area Covered by Crystalline Deposits at Each Visit | Day 7 | 10.4 percentage of lens area | Standard Deviation 7.9 |
| FID 120947A | Percentage of Lens Area Covered by Crystalline Deposits at Each Visit | Day 30 | 10.8 percentage of lens area | Standard Deviation 9.65 |
| FID 120947A | Percentage of Lens Area Covered by Crystalline Deposits at Each Visit | Day 60 | 8.8 percentage of lens area | Standard Deviation 2.5 |
| FID 120947A | Percentage of Lens Area Covered by Crystalline Deposits at Each Visit | Day 90 | 7.1 percentage of lens area | Standard Deviation 3.45 |
| FID 120947A | Percentage of Lens Area Covered by Crystalline Deposits at Each Visit | Day 135 | 11.7 percentage of lens area | Standard Deviation 7.64 |
| FID 120947A | Percentage of Lens Area Covered by Crystalline Deposits at Each Visit | Day 180 | 13.0 percentage of lens area | Standard Deviation 9.75 |
Primary
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
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FID 120947A | Percentage of Lens Area Covered by Film Deposits at Each Visit | Day 7 | 7.5 percentage of lens area | Standard Deviation 2.89 |
| FID 120947A | Percentage of Lens Area Covered by Film Deposits at Each Visit | Day 30 | 28.6 percentage of lens area | Standard Deviation 14.92 |
| FID 120947A | Percentage of Lens Area Covered by Film Deposits at Each Visit | Day 60 | 17.5 percentage of lens area | Standard Deviation 15 |
| FID 120947A | Percentage of Lens Area Covered by Film Deposits at Each Visit | Day 90 | 15.0 percentage of lens area | Standard Deviation 10 |
| FID 120947A | Percentage of Lens Area Covered by Film Deposits at Each Visit | Day 135 | 6.0 percentage of lens area | Standard Deviation 2.24 |
| FID 120947A | Percentage of Lens Area Covered by Film Deposits at Each Visit | Day 180 | 7.5 percentage of lens area | Standard Deviation 3.54 |