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The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft contact lens wearers of Japanese ethnicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FID 120947A | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FID 120947A contact lens disinfecting solution | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 |
| Number of Eyes With Film Deposits on Lens by Type at Each Visit | Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Both eyes contributed to the analysis. | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 |
| Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit | Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Both eyes contributed to the analysis. | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 |
| Percentage of Lens Area Covered by Film Deposits at Each Visit | Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. For each visit, the number analyzed represents the number of eyes with film deposits on lens, respectively. | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 |
| Percentage of Lens Area Covered by Crystalline Deposits at Each Visit | Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. For each visit, the number analyzed represents the number of eyes with film deposits on lens, respectively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Group Manager, Clinical Development | Alcon Japan, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Japan, Ltd. for Trial Locations | Tokyo | 105-6333 | Japan |
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Of the 91 enrolled, 1 subject was exited as a screen failure prior to treatment. This reporting group includes all treated subjects (90).
Subjects were recruited from 6 study centers located in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This analysis population includes all treated subjects (Full Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full Analysis Set, with non-missing response | Posted | Number | percentage of eyes | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | Eyes | Eyes |
|
Day 1 through study completion, an average of 6 months
An AE was defined as any unfavorable or unintended sign, symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FID 120977A - Subject Based Adverse Events | All subjects treated with FID 120947A contact lens disinfecting solution |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Project Lead, GCRA, Vision Care | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003263 | Contact Lenses, Hydrophilic |
| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Soft contact lenses (SCL) | Device | 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. |
|
|
| SCL preservative solution | Device | Commercially available solution for rinsing soft contact lenses |
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| Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 |
| Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit | Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using Decimal acuity, where 1.0 (equivalent to 20/20) is considered normal distance-eyesight. A line increase indicates an improvement in VA. Both eyes contributed to the analysis | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 |
| Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit | Subject recorded a response to the question, "Averaging over the last 3 days, how many hours per day did you wear your contact lenses?" Lens wear time was summarized as an estimate of the subject's daily wear, averaged over the course of 3 days prior to each scheduled visit, and measured in hours. Habitual lenses were used at the Day 0 time point. | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 |
| Lens Wear Time at Each Visit Day | Subject recorded a response to the question, "How many hours have you worn your contact lenses today?" Lens wear was measured in hours. Habitual lenses were used at the Day 0 time point. | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 |
| Average Rewetting Drop Frequency at Each Visit | Subject recorded a response to the question, "Averaging over the last 3 days, how many times per day did you use rewetting drops?" Habitual lenses were used at the Day 0 time point. | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 |
| Number of Unscheduled Lens Replacements by Reason | Subjects were dispensed enough contact lenses to follow a 2-week replacement schedule during the study. Lenses replaced at other times were considered unscheduled. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject. All lenses which were replaced are counted. Habitual lenses were used at the Day 0 time point. | Up to Day 180 |
| Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day." | Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects. Habitual lenses and habitual lens care solution were used at the Day 0 time point. | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 |
| Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear." | Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects. Habitual lenses and habitual lens care solution were used at the Day 0 time point. | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 |
| Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling." | Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects. Habitual lenses and habitual lens care solution were used at the Day 0 time point. | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Eyes |
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| 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. | Full Analysis Set | Posted | Number | eyes | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | Eyes | Eyes |
|
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| 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. | Full Analysis Set | Posted | Number | eyes | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | Eyes | Eyes |
|
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| 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. | Full Analysis Set | Posted | Mean | Standard Deviation | percentage of lens area | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | eyes | eyes |
|
|
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| 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. | Full Analysis Set | Posted | Mean | Standard Deviation | percentage of lens area | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | Eyes | Eyes |
|
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| 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 | Full Analysis Set, with non-missing response | Posted | Number | percentage of eyes | Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 | Eyes | Eyes |
|
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| 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. | Full Analysis Set, with non-missing response | Posted | Mean | Standard Deviation | hours | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 |
|
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| 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. | Full Analysis Set, with non-missing response | Posted | Mean | Standard Deviation | hours | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 |
|
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| 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. | Full Analysis Set, with non-missing response | Posted | Mean | Standard Deviation | times per day | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 |
|
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| 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. | Full Analysis Set, with specified reason for replacement. | Posted | Number | lenses | Up to Day 180 |
|
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| 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. | Full Analysis Set | Posted | Number | percentage of subjects | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 |
|
|
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| 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. | Full Analysis Set with non-missing response | Posted | Number | percentage of subjects | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 |
|
|
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| 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. | Full Analysis Set with non-missing response | Posted | Number | percentage of subjects | Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180 |
|
|
|
| 0 |
| 90 |
| 0 |
| 90 |
| 0 |
| 90 |
| EG001 | FID 120977A - Ocular Adverse Events | All eyes treated with FID 120947A contact lens disinfecting solution | 0 | 180 | 0 | 180 | 25 | 180 |
| Vision blurred | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
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| Unplanned - Bad edge |
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| Unplanned - Discoloration |
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| Unplanned - No lens in pack |
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| Unplanned - Visual Acuity |
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