| Primary | Average Daily Wear Time | Average hours per day that contact lens were worn. | Subjects included in analysis were those who completed the study and had complete data available for statistical analysis. | Posted | | Least Squares Mean | Standard Error | Hours | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Clear Care Lens Cleaning Solution (LCS) | All subjects assigned to Clear Care LCS | | OG001 | ReNU Multi Purpose Solution (MPS) | All subjects assigned to ReNU MPS |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00013.57± 0.23
- OG00113.30± 0.23
|
|
| |
| Primary | Average Daily Comfortable Wear Time | Average hours per day that contact lens were worn comfortably. | Subjects included in analysis were those who completed the study and had complete data available for statistical analysis. | Posted | | Least Squares Mean | Standard Error | Hours | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Clear Care LCS | Subjects assigned to Clear Care lens care solution | | OG001 | ReNU MPS | Subjects assigned to ReNU multi purpose solution |
| |
| Primary | Lens Comfort | Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent. | Subjects included in analysis were those who completed the study and had complete data available for statistical analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Clear Care LCS | Subjects assigned to Clear Care lens care solution | | OG001 | ReNU MPS | Subjects assigned to ReNU multi purpose solution |
| |
| Primary | Frequency of Eye Discomfort | Subjective measure of typical daily eye discomfort reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly. | Subjects included in analysis were those who completed the study and had complete data available for statistical analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Clear Care LCS | Subjects assigned to Clear Care lens care solution | | OG001 | ReNU MPS | Subjects assigned to ReNU multi purpose solution |
| |
| Primary | Frequency of Daily Lens Dryness | Subjective measure of typical daily contact lens dryness reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly. | Subjects included in analysis were those who completed the study and had complete data available for statistical analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Clear Care LCS | Subjects assigned to Clear Care lens care solution | | OG001 | ReNU MPS | Subjects assigned to ReNU multi purpose solution |
| |
| Primary | Frequency of Eye Burning/Stinging | Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly. | Subjects included in analysis were those who completed the study and had complete data available for statistical analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Clear Care LCS | Subjects assigned to Clear Care lens care solution | | OG001 | ReNU MPS | Subjects assigned to ReNU multi purpose solution |
| |
| Primary | Frequency of Itching | Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly. | Subjects included in analysis were those who completed the study and had complete data available for statistical analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Clear Care LCS | O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution | | OG001 | ReNU MPS | Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution |
| |
| Primary | Frequency of Tearing | Subjective measure of typical daily tearing related to lens wear reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly. | Subjects included in analysis were those who completed the study and had complete data available for statistical analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Clear Care LCS | Subjects assigned to Clear Care lens care solution | | OG001 | ReNU MPS | Subjects assigned to ReNU multi purpose solution |
| |
| Primary | Average Corneal Fluorescein Type Staining | staining measured over five sectors of the cornea and classified as a type of staining on a scale of 0 to 4. 0=None, 1=Micropunctate, 2=Macropunctate, 3=Coalesced Macropunctate, 4=Patch. | Subjects included in analysis were those who completed the study and had complete data available for statistical analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 24 weeks | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Clear Care LCS | Subjects assigned to Clear Care lens care solution | | OG001 | ReNU MPS | Subjects assigned to ReNU multi purpose solution |
| |
| Primary | Average Corneal Fluorescein Staining Area | corneal staining measured over 5 areas, averaged, and graded as a single score average on a scale of 0 to 10, 0=0%, 1=10%, 2=20%, 3=30%, 4=40%, 5=50%, 6=60%, 7=70%, 8=80%, 9=90%, 10=100%. | Subjects included in analysis were those who completed the study and had complete data available for statistical analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 24 weeks | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | Clear Care LCS | Subjects assigned to Clear Care lens care solution | | OG001 | ReNU MPS | Subjects assigned to ReNU multi purpose solution |
| |
| Primary | Limbal Redness | Redness at the transition zone between the white of the eye and the clear window of the eye, the cornea, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe | Subjects included in analysis were those who completed the study and had complete data available for statistical analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 24 weeks | eyes | eyes | | ID | Title | Description |
|---|
| OG000 | Clear Care LCS | Subjects assigned to Clear Care lens care solution | | OG001 | ReNU MPS | Subjects assigned to ReNU multi purpose solution |
| |
| Primary | Bulbar Redness | Redness of the blood vessels in the tissues overlaying the white of the eye, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe | Subjects included in analysis were those who completed the study and had complete data available for statistical analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 24 weeks | eyes | eyes | | ID | Title | Description |
|---|
| OG000 | Clear Care LCS | Subjects assigned to Clear Care lens care solution | | OG001 | ReNU MPS | Subjects assigned to ReNU multi purpose solution |
| |
| Primary | Lower Tarsal Redness | Redness of the blood vessels in the inner lining of the lower eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe | Subjects included in analysis were those who completed the study and had complete data available for statistical analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 24 weeks | eyes | eyes | | ID | Title | Description |
|---|
| OG000 | Clear Care LCS | Subjects assigned to Clear Care lens care solution | | OG001 | ReNU MPS | Subjects assigned to ReNU multi purpose solution |
| |
| Primary | Upper Tarsal Redness | Redness of the blood vessels in the inner lining of the upper eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe | Subjects included in analysis were those who completed the study and had complete data available for statistical analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 24 weeks | eyes | eyes | | ID | Title | Description |
|---|
| OG000 | Clear Care LCS | Subjects assigned to Clear Care lens care solution | | OG001 | ReNU MPS | Subjects assigned to ReNU multi purpose solution |
| |
| Primary | Tarsal Roughness | The roughness of the inner lining of the eyelids, measured on a 0 to 7 scale. 0=Smooth, 1=Slightly uneven, 2=Uneven surface, 3=Uneven surface with loss of transparency & superficial vessels, 4=Small papillae, poor transparency, 5=Papillae greater than 0.5mm in size, no transparency, 6=Papillae greater than 0.5mm in size, vessels inside papillae, 7=Large papillae | Subjects included in analysis were those who completed the study and had complete data available for statistical analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 24 weeks | eyes | eyes | | ID | Title | Description |
|---|
| OG000 | Clear Care LCS | Subjects assigned to Clear Care lens care solution | | OG001 | ReNU MPS | Subjects assigned to ReNU multi purpose solution |
| |
| Secondary | Intensity of Physiological Outcomes | Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible to "Solution Induced Corneal Staining (SICS)". These measures are related to intensity of outcomes, i.e. discomfort, burning, dryness, etc. with lower scores being better on a scale of 1-5. | All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported per this stratification. | Posted | | Least Squares Mean | Standard Deviation | units on a scale | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Clear Care LCS (Stainers) | Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'. | | OG001 | Clear Care LCS (Non-Stainers) | Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'. | | OG002 | ReNU MPS (Stainers) | ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'. |
|
| Secondary | Wearing Time and Comfortable Wearing Time | Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for "Solution Induced Corneal Staining (SICS)". Average wearing time and average comfortable wearing time. | All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported per this stratification. | Posted | | Least Squares Mean | Standard Deviation | hours | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Clear Care LCS (Stainers) | Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'. | | OG001 | Clear Care LCS (Non-Stainers) | Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'. | | OG002 | ReNU MPS (Stainers) | ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'. |
|
| Secondary | Physiological Responses | Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for "Solution Induced Corneal Staining (SICS)". Physiological findings are done through a slit lamp examination and are known as biomicroscopy measurements. Measures are given in terms of average score with a minimum of zero and a worse grade the higher the value with a range of 0 to 4, (tarsal roughness is 0-7 scale). | All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported by this stratification. | Posted | | Least Squares Mean | Standard Deviation | units on a scale | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Clear Care LCS (Stainers) | Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'. | | OG001 | Clear Care LCS (Non-Stainers) | Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'. | | OG002 | ReNU MPS (Stainers) |
|