Myopia
Conditions
Brief summary
The purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.
Interventions
DEVICEO2Optix contact lens
control contact lens to be worn daily for approximately 7 months for entire length of study.
DEVICEProclear contact lens
control contact lens to be worn for entire length of study.
lens solution for overnight lens disinfection
DEVICEClear Care Cleaning and Disinfecting Solution
lens solution for overnight lens disinfection
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years old. * Signed Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space. * Require a visual correction in both eyes (monovision allowed but not monofit). * Have a contact lens spherical distance requirement between +6.00D and -9.00D in both eyes. * Astigmatism of 1.00D or less in the better eye and 1.50D or less in the other eye. * Be correctable to a visual acuity of 20/30 (6/9) or better in each eye. * Have normal eyes with no evidence of abnormality or disease.
Exclusion criteria
* Requires concurrent ocular medication. * Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. * Clinically significant corneal edema, corneal vascularisation, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear. * Worn lenses on an extended wear basis in the last 3 months. * Diabetic. * Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV). * Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks. * Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study. * Abnormal lacrimal secretions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tarsal Roughness | 24 weeks | 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 |
| Limbal Redness | 24 weeks | 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 |
| Bulbar Redness | 24 weeks | 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 |
| Lower Tarsal Redness | 24 weeks | 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 |
| Upper Tarsal Redness | 24 weeks | 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 |
| Average Daily Wear Time | 24 weeks | Average hours per day that contact lens were worn. |
| Average Daily Comfortable Wear Time | 24 weeks | Average hours per day that contact lens were worn comfortably. |
| Lens Comfort | 24 weeks | Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent. |
| Frequency of Eye Discomfort | 24 weeks | 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. |
| Frequency of Daily Lens Dryness | 24 weeks | 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. |
| Frequency of Eye Burning/Stinging | 24 weeks | 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. |
| Frequency of Itching | 24 weeks | 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. |
| Frequency of Tearing | 24 weeks | 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. |
| Average Corneal Fluorescein Type Staining | 24 weeks | 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. |
| Average Corneal Fluorescein Staining Area | 24 weeks | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wearing Time and Comfortable Wearing Time | 24 weeks | 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. |
| Physiological Responses | 24 weeks | 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). |
| Intensity of Physiological Outcomes | 24 weeks | 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. |
Countries
United Kingdom, United States
Participant flow
Recruitment details
Subjects were recruited in both the US and UK and were screened, randomized, and assigned to a study arm.
Pre-assignment details
A total of 473 subjects were attempted to be enrolled. There were 27 disqualified, 2 due to incorrect care system, 1 due to non-compliance, and 24 due to non-compliance from investigator, leaving 446 subjects recruited to participate.Of those remaining, 21 failed to meet inclusion or were excluded for a total of 425 subjects who started the study.
Participants by arm
| Arm | Count |
|---|---|
| Clear Care LCS Subjects assigned to Clear Care lens care solution | 208 |
| ReNU MPS Subjects assigned to ReNU multi purpose solution | 217 |
| Total | 425 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Phase 1 (Baseline to 4 Weeks) | Lost to Follow-up | 0 | 0 | 3 | 1 |
| Phase 1 (Baseline to 4 Weeks) | poor comfort | 1 | 1 | 5 | 1 |
| Phase 1 (Baseline to 4 Weeks) | poor vision | 0 | 0 | 3 | 0 |
| Phase 1 (Baseline to 4 Weeks) | Pregnancy | 2 | 0 | 0 | 0 |
| Phase 1 (Baseline to 4 Weeks) | Protocol Violation | 1 | 1 | 1 | 0 |
| Phase 1 (Baseline to 4 Weeks) | Withdrawal by Subject | 0 | 1 | 0 | 0 |
| Phase 2 (4 Weeks to 24 Weeks) | Adverse Event | 2 | 3 | 0 | 0 |
| Phase 2 (4 Weeks to 24 Weeks) | Lost to Follow-up | 3 | 0 | 2 | 1 |
| Phase 2 (4 Weeks to 24 Weeks) | Poor comfort | 1 | 4 | 0 | 3 |
| Phase 2 (4 Weeks to 24 Weeks) | Poor vision | 1 | 1 | 1 | 0 |
| Phase 2 (4 Weeks to 24 Weeks) | Protocol Violation | 0 | 1 | 0 | 1 |
| Phase 2 (4 Weeks to 24 Weeks) | Randomization strata filled | 9 | 0 | 6 | 0 |
Baseline characteristics
| Characteristic | Clear Care LCS | ReNU MPS | Total |
|---|---|---|---|
| Age, Continuous | 33.9 years STANDARD_DEVIATION 11.8 | 33.4 years STANDARD_DEVIATION 11.3 | 33.6 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment United Kingdom | 19 participants | 19 participants | 38 participants |
| Region of Enrollment United States | 189 participants | 198 participants | 387 participants |
| Sex: Female, Male Female | 154 Participants | 150 Participants | 304 Participants |
| Sex: Female, Male Male | 54 Participants | 67 Participants | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 121 | 0 / 103 | 0 / 115 | 0 / 107 |
| serious Total, serious adverse events | 0 / 121 | 0 / 103 | 0 / 115 | 1 / 107 |
Outcome results
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%.
Time frame: 24 weeks
Population: Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Clear Care Lens Cleaning Solution (LCS) | Average Corneal Fluorescein Staining Area | 0.27 units on a scale | Standard Error 0.09 |
| ReNU Multi Purpose Solution (MPS) | Average Corneal Fluorescein Staining Area | 0.99 units on a scale | Standard Error 0.09 |
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.
Time frame: 24 weeks
Population: Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Clear Care Lens Cleaning Solution (LCS) | Average Corneal Fluorescein Type Staining | 0.16 units on a scale | Standard Error 0.02 |
| ReNU Multi Purpose Solution (MPS) | Average Corneal Fluorescein Type Staining | 0.36 units on a scale | Standard Error 0.02 |
Primary
Average Daily Comfortable Wear Time
Average hours per day that contact lens were worn comfortably.
Time frame: 24 weeks
Population: Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Clear Care Lens Cleaning Solution (LCS) | Average Daily Comfortable Wear Time | 11.96 Hours | Standard Error 0.29 |
| ReNU Multi Purpose Solution (MPS) | Average Daily Comfortable Wear Time | 11.39 Hours | Standard Error 0.29 |
Primary
Average Daily Wear Time
Average hours per day that contact lens were worn.
Time frame: 24 weeks
Population: Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Clear Care Lens Cleaning Solution (LCS) | Average Daily Wear Time | 13.57 Hours | Standard Error 0.23 |
| ReNU Multi Purpose Solution (MPS) | Average Daily Wear Time | 13.30 Hours | Standard Error 0.23 |
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
Time frame: 24 weeks
Population: Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Clear Care Lens Cleaning Solution (LCS) | Bulbar Redness | 0.50 units on a scale | Standard Error 0.03 |
| ReNU Multi Purpose Solution (MPS) | Bulbar Redness | 0.56 units on a scale | Standard Error 0.03 |
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.
Time frame: 24 weeks
Population: Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Clear Care Lens Cleaning Solution (LCS) | Frequency of Daily Lens Dryness | 0.66 units on a scale | Standard Error 0.05 |
| ReNU Multi Purpose Solution (MPS) | Frequency of Daily Lens Dryness | 0.68 units on a scale | Standard Error 0.05 |
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.
Time frame: 24 weeks
Population: Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Clear Care Lens Cleaning Solution (LCS) | Frequency of Eye Burning/Stinging | 0.31 units on a scale | Standard Error 0.04 |
| ReNU Multi Purpose Solution (MPS) | Frequency of Eye Burning/Stinging | 0.31 units on a scale | Standard Error 0.04 |
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.
Time frame: 24 weeks
Population: Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Clear Care Lens Cleaning Solution (LCS) | Frequency of Eye Discomfort | 0.36 units on a scale | Standard Error 0.05 |
| ReNU Multi Purpose Solution (MPS) | Frequency of Eye Discomfort | 0.46 units on a scale | Standard Error 0.05 |
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.
Time frame: 24 weeks
Population: Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Clear Care Lens Cleaning Solution (LCS) | Frequency of Itching | 0.21 units on a scale | Standard Error 0.03 |
| ReNU Multi Purpose Solution (MPS) | Frequency of Itching | 0.21 units on a scale | Standard Error 0.03 |
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.
Time frame: 24 weeks
Population: Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Clear Care Lens Cleaning Solution (LCS) | Frequency of Tearing | 0.16 units on a scale | Standard Error 0.03 |
| ReNU Multi Purpose Solution (MPS) | Frequency of Tearing | 0.15 units on a scale | Standard Error 0.03 |
Primary
Lens Comfort
Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.
Time frame: 24 weeks
Population: Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Clear Care Lens Cleaning Solution (LCS) | Lens Comfort | 8.63 units on a scale | Standard Error 0.13 |
| ReNU Multi Purpose Solution (MPS) | Lens Comfort | 8.25 units on a scale | Standard Error 0.13 |
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
Time frame: 24 weeks
Population: Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Clear Care Lens Cleaning Solution (LCS) | Limbal Redness | 0.44 units on a scale | Standard Error 0.03 |
| ReNU Multi Purpose Solution (MPS) | Limbal Redness | 0.49 units on a scale | Standard Error 0.03 |
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
Time frame: 24 weeks
Population: Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Clear Care Lens Cleaning Solution (LCS) | Lower Tarsal Redness | 0.51 units on a scale | Standard Error 0.03 |
| ReNU Multi Purpose Solution (MPS) | Lower Tarsal Redness | 0.57 units on a scale | Standard Error 0.03 |
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
Time frame: 24 weeks
Population: Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Clear Care Lens Cleaning Solution (LCS) | Tarsal Roughness | 0.75 units on a scale | Standard Error 0.05 |
| ReNU Multi Purpose Solution (MPS) | Tarsal Roughness | 0.87 units on a scale | Standard Error 0.05 |
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
Time frame: 24 weeks
Population: Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Clear Care Lens Cleaning Solution (LCS) | Upper Tarsal Redness | 0.48 units on a scale | Standard Error 0.03 |
| ReNU Multi Purpose Solution (MPS) | Upper Tarsal Redness | 0.55 units on a scale | Standard Error 0.03 |
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.
Time frame: 24 weeks
Population: All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported per this stratification.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Clear Care Lens Cleaning Solution (LCS) | Intensity of Physiological Outcomes | Intensity of Itching | 1.94 units on a scale | Standard Deviation 0.93 |
| Clear Care Lens Cleaning Solution (LCS) | Intensity of Physiological Outcomes | Intensity of Burning/Stinging | 2.24 units on a scale | Standard Deviation 1.3 |
| Clear Care Lens Cleaning Solution (LCS) | Intensity of Physiological Outcomes | Intensity of Tearing | 2.00 units on a scale | Standard Deviation 1.13 |
| Clear Care Lens Cleaning Solution (LCS) | Intensity of Physiological Outcomes | Intensity of Dryness | 2.20 units on a scale | Standard Deviation 0.95 |
| Clear Care Lens Cleaning Solution (LCS) | Intensity of Physiological Outcomes | Intensity of Discomfort/Pain | 2.00 units on a scale | Standard Deviation 1.22 |
| ReNU Multi Purpose Solution (MPS) | Intensity of Physiological Outcomes | Intensity of Dryness | 2.69 units on a scale | Standard Deviation 1.18 |
| ReNU Multi Purpose Solution (MPS) | Intensity of Physiological Outcomes | Intensity of Itching | 1.70 units on a scale | Standard Deviation 1.1 |
| ReNU Multi Purpose Solution (MPS) | Intensity of Physiological Outcomes | Intensity of Tearing | 1.61 units on a scale | Standard Deviation 0.78 |
| ReNU Multi Purpose Solution (MPS) | Intensity of Physiological Outcomes | Intensity of Burning/Stinging | 2.10 units on a scale | Standard Deviation 1.16 |
| ReNU Multi Purpose Solution (MPS) | Intensity of Physiological Outcomes | Intensity of Discomfort/Pain | 2.41 units on a scale | Standard Deviation 1.14 |
| ReNU MPS (Stainers) | Intensity of Physiological Outcomes | Intensity of Dryness | 2.40 units on a scale | Standard Deviation 1.06 |
| ReNU MPS (Stainers) | Intensity of Physiological Outcomes | Intensity of Discomfort/Pain | 2.48 units on a scale | Standard Deviation 1.09 |
| ReNU MPS (Stainers) | Intensity of Physiological Outcomes | Intensity of Burning/Stinging | 2.35 units on a scale | Standard Deviation 1.09 |
| ReNU MPS (Stainers) | Intensity of Physiological Outcomes | Intensity of Itching | 2.24 units on a scale | Standard Deviation 1.23 |
| ReNU MPS (Stainers) | Intensity of Physiological Outcomes | Intensity of Tearing | 2.38 units on a scale | Standard Deviation 1.04 |
| ReNU MPS (Non-Stainers) | Intensity of Physiological Outcomes | Intensity of Itching | 1.67 units on a scale | Standard Deviation 0.84 |
| ReNU MPS (Non-Stainers) | Intensity of Physiological Outcomes | Intensity of Burning/Stinging | 1.76 units on a scale | Standard Deviation 1 |
| ReNU MPS (Non-Stainers) | Intensity of Physiological Outcomes | Intensity of Discomfort/Pain | 2.24 units on a scale | Standard Deviation 1.17 |
| ReNU MPS (Non-Stainers) | Intensity of Physiological Outcomes | Intensity of Dryness | 2.25 units on a scale | Standard Deviation 1.14 |
| ReNU MPS (Non-Stainers) | Intensity of Physiological Outcomes | Intensity of Tearing | 1.73 units on a scale | Standard Deviation 0.79 |
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).
Time frame: 24 weeks
Population: All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported by this stratification.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Clear Care Lens Cleaning Solution (LCS) | Physiological Responses | Upper Tarsal Hyperemia | 0.51 units on a scale | Standard Deviation 0.6 |
| Clear Care Lens Cleaning Solution (LCS) | Physiological Responses | Lower Tarsal Hyperemia | 0.50 units on a scale | Standard Deviation 0.63 |
| Clear Care Lens Cleaning Solution (LCS) | Physiological Responses | Tarsal Roughness | 0.97 units on a scale | Standard Deviation 0.74 |
| Clear Care Lens Cleaning Solution (LCS) | Physiological Responses | Corneal Staining | 0.20 units on a scale | Standard Deviation 0.25 |
| Clear Care Lens Cleaning Solution (LCS) | Physiological Responses | Limbal Hyperemia | 0.52 units on a scale | Standard Deviation 0.66 |
| Clear Care Lens Cleaning Solution (LCS) | Physiological Responses | Bulbar Hyperemia | 0.51 units on a scale | Standard Deviation 0.59 |
| ReNU Multi Purpose Solution (MPS) | Physiological Responses | Lower Tarsal Hyperemia | 0.48 units on a scale | Standard Deviation 0.54 |
| ReNU Multi Purpose Solution (MPS) | Physiological Responses | Bulbar Hyperemia | 0.48 units on a scale | Standard Deviation 0.54 |
| ReNU Multi Purpose Solution (MPS) | Physiological Responses | Corneal Staining | 0.11 units on a scale | Standard Deviation 0.19 |
| ReNU Multi Purpose Solution (MPS) | Physiological Responses | Limbal Hyperemia | 0.39 units on a scale | Standard Deviation 0.5 |
| ReNU Multi Purpose Solution (MPS) | Physiological Responses | Upper Tarsal Hyperemia | 0.46 units on a scale | Standard Deviation 0.54 |
| ReNU Multi Purpose Solution (MPS) | Physiological Responses | Tarsal Roughness | 0.69 units on a scale | Standard Deviation 0.75 |
| ReNU MPS (Stainers) | Physiological Responses | Lower Tarsal Hyperemia | 0.55 units on a scale | Standard Deviation 0.68 |
| ReNU MPS (Stainers) | Physiological Responses | Limbal Hyperemia | 0.46 units on a scale | Standard Deviation 0.58 |
| ReNU MPS (Stainers) | Physiological Responses | Tarsal Roughness | 0.90 units on a scale | Standard Deviation 0.77 |
| ReNU MPS (Stainers) | Physiological Responses | Bulbar Hyperemia | 0.53 units on a scale | Standard Deviation 0.62 |
| ReNU MPS (Stainers) | Physiological Responses | Upper Tarsal Hyperemia | 0.51 units on a scale | Standard Deviation 0.6 |
| ReNU MPS (Stainers) | Physiological Responses | Corneal Staining | 0.52 units on a scale | Standard Deviation 0.56 |
| ReNU MPS (Non-Stainers) | Physiological Responses | Tarsal Roughness | 0.84 units on a scale | Standard Deviation 0.89 |
| ReNU MPS (Non-Stainers) | Physiological Responses | Upper Tarsal Hyperemia | 0.59 units on a scale | Standard Deviation 0.61 |
| ReNU MPS (Non-Stainers) | Physiological Responses | Corneal Staining | 0.32 units on a scale | Standard Deviation 0.38 |
| ReNU MPS (Non-Stainers) | Physiological Responses | Limbal Hyperemia | 0.43 units on a scale | Standard Deviation 0.51 |
| ReNU MPS (Non-Stainers) | Physiological Responses | Lower Tarsal Hyperemia | 0.59 units on a scale | Standard Deviation 0.61 |
| ReNU MPS (Non-Stainers) | Physiological Responses | Bulbar Hyperemia | 0.52 units on a scale | Standard Deviation 0.59 |
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.
Time frame: 24 weeks
Population: All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported per this stratification.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Clear Care Lens Cleaning Solution (LCS) | Wearing Time and Comfortable Wearing Time | Average Wearing Time | 14.06 hours | Standard Deviation 2.24 |
| Clear Care Lens Cleaning Solution (LCS) | Wearing Time and Comfortable Wearing Time | Average Comfortable Wearing Time | 12.42 hours | Standard Deviation 3.17 |
| ReNU Multi Purpose Solution (MPS) | Wearing Time and Comfortable Wearing Time | Average Comfortable Wearing Time | 11.93 hours | Standard Deviation 3.47 |
| ReNU Multi Purpose Solution (MPS) | Wearing Time and Comfortable Wearing Time | Average Wearing Time | 13.63 hours | Standard Deviation 2.55 |
| ReNU MPS (Stainers) | Wearing Time and Comfortable Wearing Time | Average Wearing Time | 13.49 hours | Standard Deviation 2.67 |
| ReNU MPS (Stainers) | Wearing Time and Comfortable Wearing Time | Average Comfortable Wearing Time | 11.35 hours | Standard Deviation 3.35 |
| ReNU MPS (Non-Stainers) | Wearing Time and Comfortable Wearing Time | Average Comfortable Wearing Time | 11.75 hours | Standard Deviation 3.67 |
| ReNU MPS (Non-Stainers) | Wearing Time and Comfortable Wearing Time | Average Wearing Time | 13.33 hours | Standard Deviation 2.28 |