Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in gas permeable lens wearers.
Subjects with normal eyes (other than correction for refractive error) successfully wearing silicone acrylate or fluoro silicone acrylate gas permeable contact lenses were randomized 2:1 to receive either the investigational or commercial contact lens solution for daily use throughout the study (90 days).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FID 120974A | Experimental | FID 120947A contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days |
|
| Boston Simplus | Active Comparator | Boston Simplus multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FID 120947A contact lens disinfecting solution | Device | Investigational 3% hydrogen peroxide solution intended for simultaneous cleaning, protein removal, disinfecting and storage of gas permeable contact lenses |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 7, Day 30, Day 60, Day 90 |
| Percentage of Subjects With Crystalline Deposits by Type | Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis. | Day 7, Day 30, Day 60, Day 90 |
| Percentage of Subjects With Film Deposits by Type | Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis. | Day 7, Day 30, Day 60, Day 90 |
| Average Residual Lens Lysozyme | Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lieve Convents, Lead CSM | Alcon Research | Study Director |
Not provided
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).
Subjects were recruited from 12 study centers located in the US.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | FID 120974A | Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days |
| FG001 | Boston Simplus | Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Boston Simplus multi-action solution | Device | 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 |
|
| Gas permeable contact lenses | Device | 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). |
|
|
| Day 90/Early Exit |
| Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change | Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis. | Baseline (Day 0), Day 7, Day 30, Day 60, Day 90 |
| Average Lens Wear Time | Subject recorded a response to the question, "Averaging over the last 3 days, how many hours per day did you wear your contact lenses?" Lens wear time was measured in hours. | Day 7, Day 30, Day 60, Day 90 |
| Number of Unscheduled Lens Replacements by Reason | No lens replacements were planned during the study. Lenses could be replaced as needed due to loss, damage, or as deemed necessary by the Investigator. If it became necessary to replace a lens, the subject was examined at an unscheduled visit. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject. | Up to Day 90 |
| Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day." | Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects. | Day 7, Day 30, Day 60, Day 90 |
| Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear." | Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects. | Day 7, Day 30, Day 60, Day 90 |
| Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling." | Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects. | Day 7, Day 30, Day 60, Day 90 |
| Crystalline Deposit Area Covered | Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis. | Day 7, Day 30, Day 60, Day 90 |
| Film Deposit Area Covered | Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis. | Day 7, Day 30, Day 60, Day 90 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
This analysis population includes all randomized subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | FID 120974A | Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days |
| BG001 | Boston Simplus | Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 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. | This analysis population includes all subjects with data at visit. | Posted | Number | percentage of subjects | Day 7, Day 30, Day 60, Day 90 |
|
|
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | percentage of subjects | Day 7, Day 30, Day 60, Day 90 |
|
| |||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | percentage of subjects | Day 7, Day 30, Day 60, Day 90 |
|
| |||||||||||||||||||||||||||||||||||||
| 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. | This analysis population includes all randomized subjects. | Posted | Mean | Standard Deviation | micrograms per lens | Day 90/Early Exit |
|
| ||||||||||||||||||||||||||||||||||||
| 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. | This analysis population includes all subjects with data at visit. | Posted | Number | percentage of subjects | Baseline (Day 0), Day 7, Day 30, Day 60, Day 90 |
|
| |||||||||||||||||||||||||||||||||||||
| 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. | This analysis population includes all subjects with data at visit. | Posted | Mean | Standard Deviation | Hours | Day 7, Day 30, Day 60, Day 90 |
|
| ||||||||||||||||||||||||||||||||||||
| 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. | This analysis population includes all randomized subjects. | Posted | Number | lenses | Up to Day 90 |
|
| |||||||||||||||||||||||||||||||||||||
| 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. | This analysis population includes all subjects with data at visit. | Posted | Number | percentage of subjects | Day 7, Day 30, Day 60, Day 90 |
|
| |||||||||||||||||||||||||||||||||||||
| 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. | This analysis population includes all subjects with data at visit. | Posted | Number | percentage of subjects | Day 7, Day 30, Day 60, Day 90 |
|
| |||||||||||||||||||||||||||||||||||||
| 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. | This analysis population includes all subjects with data at visit. | Posted | Number | percentage of subjects | Day 7, Day 30, Day 60, Day 90 |
|
| |||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of lens area | Day 7, Day 30, Day 60, Day 90 |
|
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of lens area | Day 7, Day 30, Day 60, Day 90 |
|
|
Adverse events (AEs) were collected for the duration of the study (Nov 2013 - May 2014). AEs were obtained as solicited and volunteered comments from subjects and as observations by the study Investigator as outlined in the study protocol.
AEs were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device or control product. AEs are reported as pre-treatment and treatment-emergent.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-treatment | All subjects who consented to participate in the study prior to exposure to investigational product | 0 | 112 | 0 | 112 | ||
| EG001 | FID 120974A | All subjects who were exposed to FID 120947A | 0 | 71 | 0 | 71 | ||
| EG002 | Boston Simplus | All subjects who were exposed to Boston Simplus | 0 | 35 | 0 | 35 |
Not provided
Not provided
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Lead, GCRA | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| D006956 | Hyperopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
| Male |
|
| Day 60 |
|
| Day 90 |
|
| Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|