| Primary | Vision Satisfaction in Bright Lighting - 2-Week Questionnaire | Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement "I am satisfied with the quality of my vision in bright lighting with these contact lenses" using a 5-point agreement Likert scale (Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree). In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the primary endpoint data summary. The number of missing responses in each lens group was reported. | All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing responses was reported for each endpoint at each timepoint. | Posted | | Number | | Responses | | 2-week questionnaire follow-up | | | | ID | Title | Description |
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| OG000 | Test | Subjects that wore the Test lens during the study. | | OG001 | Control | Subjects that wore the Control lens during the study. |
| | | Title | Denominators | Categories |
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| Strongly Agree | | | | Agree | | |
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| Primary | Vision Satisfaction in Bright Lighting - 4-Month Questionnaire | Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement "I am satisfied with the quality of my vision in bright lighting with these contact lenses" using a 5-point agreement Likert scale (Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree). In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the primary endpoint data summary. The number of missing responses in each lens group was reported. | all subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing responses was reported for each endpoint at each timepoint. | Posted | | Number | | Responses | | 4-month questionnaire follow-up | | | | ID | Title | Description |
|---|
| OG000 | Test | Subjects that wore the Test lens during the study. | | OG001 | Control | Subjects that wore the Control lens during the study. |
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| Primary | Vision Satisfaction in Bright Lighting - 12-Month Questionnaire | Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement "I am satisfied with the quality of my vision in bright lighting with these contact lenses" using a 5-point agreement Likert scale (Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree). In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the primary endpoint data summary. | All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing responses was reported for each endpoint at each timepoint. | Posted | | Number | | Responses | | 12-month questionnaire follow-up | | | | ID | Title | Description |
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| OG000 | Test | Subjects that wore the Test lens during the study. | | OG001 | Control | Subjects that wore the Control lens during the study. |
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| Secondary | Overall Quality of Vision - 2-Week Questionnaire | Overall quality of vision was assessed subjectively using the item "I am satisfied with the overall quality of my vision with these contact lenses". The item used a 5-point agreement scale: Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported. | All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing data was reported for each endpoint at each timepoint. | Posted | | Number | | Responses | | 2-week questionnaire follow-up | | | | ID | Title | Description |
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| OG000 | Test | Subjects that wore the Test lens during the study. | | OG001 | Control | Subjects that wore the Control lens during the study. |
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| Secondary | Overall Quality of Vision - 4-Month Questionnaire | Overall quality of vision was assessed subjectively using the item "I am satisfied with the overall quality of my vision with these contact lenses". The item used a 5-point agreement scale: Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported. | All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing data was reported for each endpoint at each timepoint. | Posted | | Number | | Responses | | 4-month questionnaire follow-up | | | | ID | Title | Description |
|---|
| OG000 | Test | Subjects that wore the Test lens during the study. | | OG001 | Control | Subjects that wore the Control lens during the study. |
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| Secondary | Overall Quality of Vision - 12-Month Questionnaire | Overall quality of vision was assessed subjectively using the item "I am satisfied with the overall quality of my vision with these contact lenses". The item used a 5-point agreement scale: Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported. | All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing data was reported for each endpoint at each timepoint. | Posted | | Number | | Responses | | 12-month questionnaire follow-up | | | | ID | Title | Description |
|---|
| OG000 | Test | Subjects that wore the Test lens during the study. | | OG001 | Control | Subjects that wore the Control lens during the study. |
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| Secondary | Overall Comfort - 2-Week Questionnaire | Overall comfort was assessed using the item "How would you rate the overall comfort of these contact lenses?". The item used the 5-point excellence scale, Excellent, Very Good, Good, Fair, and Poor. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported. | All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing data was reported for each endpoint at each timepoint. | Posted | | Number | | Responses | | 2-week questionnaire follow-up | | | | ID | Title | Description |
|---|
| OG000 | Test | Subjects that wore the Test lens during the study. | | OG001 | Control | Subjects that wore the Control lens during the study. |
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| Secondary | Overall Comfort - 4-Month Questionnaire | Overall comfort was assessed using the item "How would you rate the overall comfort of these contact lenses?". The item used the 5-point excellence scale, Excellent, Very Good, Good, Fair, and Poor. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported. | All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing data was reported for each endpoint at each timepoint. | Posted | | Number | | Responses | | 4-month questionnaire follow-up | | | | ID | Title | Description |
|---|
| OG000 | Test | Subjects that wore the Test lens during the study. | | OG001 | Control | Subjects that wore the Control lens during the study. |
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| Secondary | Overall Comfort - 12-Month Questionnaire | Overall comfort was assessed using the item "How would you rate the overall comfort of these contact lenses?". The item used the 5-point excellence scale, Excellent, Very Good, Good, Fair, and Poor. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported. | All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing data was reported for each endpoint at each timepoint. | Posted | | Number | | Responses | | 12-month questionnaire follow-up | | | | ID | Title | Description |
|---|
| OG000 | Test | Subjects that wore the Test lens during the study. | | OG001 | Control | Subjects that wore the Control lens during the study. |
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| Secondary | Pulfrich Effect | Pulfrich effect was assessed subjectively using the item "While wearing these lenses, my depth perception of moving objects has NOT been impacted". Subjects who disagreed or strongly disagreed with the statement were considered to have experienced the Pulfrich effect. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. | All subjects in the full analysis population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. There were 58 subjects in Full Analysis population, but 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the secondary endpoint data summary. | Posted | | Number | | Number of responses | | 2-week, 4-month, and 12-month questionnaire follow-up | | | | ID | Title | Description |
|---|
| OG000 | Test | Subjects that wore the Test lens during the study. | | OG001 | Control | Subjects that wore the Control lens during the study. |
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| Secondary | Serious or Significant Adverse Events | A serious adverse event is any untoward medical occurrence that is potentially sight-threatening, requires hospitalization, results in persistent or significant disability / incapacity, or requires intervention to prevent permanent damage. Significant adverse events are usually symptomatic and warrant discontinuation (temporary or permanent) of the test article (excluding serious adverse events). | The full analysis set including all enrolled subjects (signed consent form) regardless of subsequent withdrawal from study or deviation from protocol. | Posted | | Number | | Number of adverse events | | Throughout the duration of the study, up to 12 months | | | | ID | Title | Description |
|---|
| OG000 | Test | Subjects that wore the Test lens during the study. | | OG001 | Control | Subjects that wore the Control lens during the study. |
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