| Primary | Overall Comfort | Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent | Analysis includes participants who completed the protocol and had no missing data (n=240) | Posted | | Least Squares Mean | Standard Error | Units on a scale | | at 1 week of wear. | | | | ID | Title | Description |
|---|
| OG000 | Narafilcon A | soft contact lens worn as a daily disposable modality for one week | | OG001 | Nelfilcon A | soft contact lens worn as a daily disposable modality for one week |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0003.903± 0.1446
- OG0013.349± 0.1389
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Alternative hypothesis: narafilcon A is superior to nelfilcon A | Mixed Models Analysis | | | | Mean Difference (Final Values) | 0.554 | Standard Error of the Mean | 0.1943 | | 97.47 | 0.1721 | 0.554 | | | The mean difference is narafilcon A minus nelfilcon A. | No | Superiority or Other | | |
|
| Primary | Measured Limbal Hyperemia | Measurement of redness of the limbus, graded using half-grade increments using the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. | Analysis includes participants who completed the study per protocol and had no missing data (n=243). | Posted | | Least Squares Mean | Standard Error | Units on a scale | | at 1 week of wear. | | | | ID | Title | Description |
|---|
| OG000 | Narafilcon A | soft contact lens worn as a daily disposable modality for one week | | OG001 | Nelfilcon A | soft contact lens worn as a daily disposable modality for one week |
| |
| Secondary | Overall Handling | Rating of overall ease of handling using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent. | Analysis includes participants who completed the study per protocol and had no missing data (n=240). | Posted | | Least Squares Mean | Standard Error | Units on a scale | | at 1 week of wear | | | | ID | Title | Description |
|---|
| OG000 | Narafilcon A | soft contact lens worn as a daily disposable modality for one week | | OG001 | Nelfilcon A | soft contact lens worn as a daily disposable modality for one week |
| |
| Secondary | How Comfortable Eyes Feel at the End of the Day | Rating of "How comfortable did your eyes feel at the end of the day when wearing the contact lenses provided" using the following scale: 1=extremely uncomfortable, 2= very uncomfortable, 3=slightly uncomfortable, 4=comfortable, 5=very comfortable. | Analysis includes participants who completed the study per protocol and had no missing data. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | at 1 week wear | | | | ID | Title | Description |
|---|
| OG000 | Narafilcon A | soft contact lens worn as a daily disposable modality for one week | | OG001 | Nelfilcon A | soft contact lens worn as a daily disposable modality for one week |
| |
| Secondary | End of Day Comfort | Rating of comfort at the end of the day using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent | Analysis includes participants who completed the study per protocol and had no missing data (n=240). | Posted | | Least Squares Mean | Standard Error | Units on a scale | | at 1 week of wear | | | | ID | Title | Description |
|---|
| OG000 | Narafilcon A | soft contact lens worn as a daily disposable modality for one week | | OG001 | Nelfilcon A | soft contact lens worn as a daily disposable modality for one week |
| |
| Secondary | Initial Comfort | Rating of "comfort immediately when you first put them on" using the following scale: 0=N/A, 1= Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent. | Analysis includes participants who completed the study per protocol and had no missing data (n=240). | Posted | | Least Squares Mean | Standard Error | Units on a scale | | at 1 week | | | | ID | Title | Description |
|---|
| OG000 | Narafilcon A | soft contact lens worn as a daily disposable modality for one week | | OG001 | Nelfilcon A | soft contact lens worn as a daily disposable modality for one week |
| |
| Secondary | Inferior Region Corneal Staining | National Eye Institute (NEI) 0-3 scale: grade 0=normal, grade 1=mild, grade 2=moderate, grade 3=severe. | Analysis includes participants who completed the study per protocol and had no missing data (n=243). | Posted | | Least Squares Mean | Standard Error | Units on a scale | | at 1 week of wear | | | | ID | Title | Description |
|---|
| OG000 | Narafilcon A | soft contact lens worn as a daily disposable modality for one week | | OG001 | Nelfilcon A | soft contact lens worn as a daily disposable modality for one week |
| |