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The purpose of this study is to assess improvement of palpebral roughness and associated symptoms with 3 months use of Clear Care®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clear Care | Experimental | Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days |
|
| Habitual MPS | Active Comparator | Habitual contact lens solution used with habitual contact lenses for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrogen peroxide-based contact lens solution | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90 | Lid papillae (bumps on the inner eyelid) were assessed by the investigator using slit-lamp biomicroscopy and classified independently for the four palpebral zones (upper lid=1-3; lower lid=4) on a 5-point forced choice scale, where 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum of the four zones was selected for the analysis. Both eyes were included in the model for analysis. A higher change value indicates a larger reduction in the severity of the lid papillae. | Baseline (Day 0), Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Top 2 Box Percentage Agreement for "My Lenses Feel Like New" at Day 90 | As interpreted and reported by the subject on a questionnaire. A 5-point Likert scale was used, where 1=strongly disagree; 2=disagree; 3=undecided; 4=agree; 5=strongly agree. The Top-2-box response (agree, strongly agree) was calculated and reported as a percentage of all responses. | Day 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Zoota, MPH | Alcon Research | Study Director |
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Of the 142 enrolled, 8 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (134).
Subjects were recruited from 12 study centers located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clear Care | Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days |
| FG001 | Habitual MPS | Habitual contact lens solution used with habitual contact lenses for 90 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This analysis group includes all subjects who were exposed to a study regimen.
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| ID | Title | Description |
|---|---|---|
| BG000 | Clear Care | Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days |
| BG001 | Habitual MPS | Habitual contact lens solution used with habitual contact lenses for 90 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90 | Lid papillae (bumps on the inner eyelid) were assessed by the investigator using slit-lamp biomicroscopy and classified independently for the four palpebral zones (upper lid=1-3; lower lid=4) on a 5-point forced choice scale, where 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum of the four zones was selected for the analysis. Both eyes were included in the model for analysis. A higher change value indicates a larger reduction in the severity of the lid papillae. | This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed. Here, "n" is subjects with non-missing values at the specific time point for each arm group, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Day 90 |
|
Adverse events (AEs) were collected for the duration of the study (DEC 2013 - MAY 2014). This analysis group includes all subjects who were exposed to a study regimen.
An AE was 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 medical device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clear Care | Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessie Lemp, DrPH, GMA Brand Lead | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Habitual contact lens solution |
| Device |
Biguanide-preserved |
|
| Habitual contact lenses | Device | Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule |
|
| Mean Frequency Score for Symptoms of Grittiness at Day 90 | As interpreted and reported by the subject on a questionnaire. The subject was asked, "During a typical day in the past 2 weeks, how often did your eyes feel gritty and/or scratchy while wearing your contact lenses?" and responded on a 5-point scale (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Frequently; 5 = Constantly). | Day 90 |
| Mean Frequency Score for Symptoms of Dryness at Day 90 | As reported and interpreted by the subject on a questionnaire. The subject was asked "During a typical day in the past 2 weeks, how often did your eyes feel dry?" and responded on a 5-point scale ((0 = Never; 1 = Rarely; 2 = Sometimes; 3 = Frequently; 4 = Constantly). | Day 90 |
| Subject Non-Compliant |
|
| Failed Inclusion/Exclusion Criteria |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | Clear Care, Right Eye | Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days |
| OG001 | Clear Care, Left Eye | Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days |
| OG002 | Habitual MPS, Right Eye | Habitual contact lens solution used with habitual contact lenses for 90 days |
| OG003 | Habitual MPS, Left Eye | Habitual contact lens solution used with habitual contact lenses for 90 days |
|
|
| Secondary | Top 2 Box Percentage Agreement for "My Lenses Feel Like New" at Day 90 | As interpreted and reported by the subject on a questionnaire. A 5-point Likert scale was used, where 1=strongly disagree; 2=disagree; 3=undecided; 4=agree; 5=strongly agree. The Top-2-box response (agree, strongly agree) was calculated and reported as a percentage of all responses. | This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed. | Posted | Number | percentage of subjects | Day 90 |
|
|
|
| Secondary | Mean Frequency Score for Symptoms of Grittiness at Day 90 | As interpreted and reported by the subject on a questionnaire. The subject was asked, "During a typical day in the past 2 weeks, how often did your eyes feel gritty and/or scratchy while wearing your contact lenses?" and responded on a 5-point scale (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Frequently; 5 = Constantly). | This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Day 90 |
|
|
|
| Secondary | Mean Frequency Score for Symptoms of Dryness at Day 90 | As reported and interpreted by the subject on a questionnaire. The subject was asked "During a typical day in the past 2 weeks, how often did your eyes feel dry?" and responded on a 5-point scale ((0 = Never; 1 = Rarely; 2 = Sometimes; 3 = Frequently; 4 = Constantly). | This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed. Here, "n" is subjects with non-missing values at the specific time point for each arm group, respectively. | Posted | Mean | Standard Deviation | units on a scale | Day 90 |
|
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| EG001 | Habitual MPS | Habitual contact lens solution used with habitual contact lenses for 90 days | 0 | 68 | 0 | 68 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.