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| Name | Class |
|---|---|
| University of Iowa | OTHER |
| Alcon Research | INDUSTRY |
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The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across three lens care regimens in new contact lens wearers.
An estimated 40 million people in the United States wear contact lenses, with approximately 38 million soft lens wearers and 2 million rigid gas permeable lens wearers. The ocular surface has been shown to respond to the introduction of foreign materials with upregulation of proinflammatory mediators, leading to an increase in inflammation. The corneal can show a foreign body immune response to contact lenses. The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across the three lens care regimens in new contact lens wearers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPTI-FREE® RepleniSH® | Active Comparator | 33 participants will be assigned to use this lens care regimen during the six-week assessment period |
|
| Clear Care® | Active Comparator | 33 participants will be assigned to use this lens care regimen during the six-week assessment period |
|
| ReNu MultiPlus® MultiPurpose Solution | Active Comparator | 33 participants will be assigned to use this lens care regimen during the six-week assessment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReNu MultiPlus® MultiPurpose Solution | Drug | Contact lens care regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Epithelial Immune Dendritic Cell Density (Central Cornea) | The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. | Six weeks |
| Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea) | The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. | Six weeks |
| Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea) | The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. | Six weeks |
| Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea) | The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. | Six weeks |
| Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea) | The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. | Six weeks |
| Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events | The safety analysis will be based on slit-lamp findings, corrected visual acuity (Snellen) and adverse events (if any). No inferential statistical analyses are planned for any safety variable. | Six weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedram Hamrah, MD | Massachusetts Eye and Ear Infirmary | Principal Investigator |
| Christine Sindt, OD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242-1091 | United States | ||
| Massachusetts Eye and Ear Infirmary |
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127 subjects were screened, out of which 94 were successfully enrolled and 35 were screenfailed due to non-normal clinical findings. Of the enrolled, 10 did not complete the study visits.
94 Neophyte contact lens wearers were fitted for one of 3 types of contact lenses (Bausch and Lomb PureVision; Vistakon Acuvue Oasys or Cooper Vision Biofinity) and were then randomized into one of three test articles (care regimens): OptiFree RepleniSH Multi-Purpose Disinfecting Solution, Clear Care or ReNu MultiPlus Multi-Purpose Solution.
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| ID | Title | Description |
|---|---|---|
| FG000 | OPTI-FREE® RepleniSH® | 33 participants will be assigned to use this lens care regimen during the six-week assessment period |
| FG001 | Clear Care® | 33 participants will be assigned to use this lens care regimen during the six-week assessment period |
| FG002 | ReNu MultiPlus® MultiPurpose Solution | 33 participants will be assigned to use this lens care regimen during the six-week assessment period |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OPTI-FREE® RepleniSH® | 33 participants will be assigned to use this lens care regimen during the six-week assessment period |
| BG001 | Clear Care® | 33 participants will be assigned to use this lens care regimen during the six-week assessment period |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Corneal Epithelial Immune Dendritic Cell Density (Central Cornea) | The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. | Participants who completed all visits were analyzed. | Posted | Mean | Standard Error | cells/mm2 | Six weeks | eyes | eyes |
|
Six weeks
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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 | OPTI-FREE® RepleniSH® | 33 participants will be assigned to use this lens care regimen during the six-week assessment period |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pedram Hamrah | Massachusetts Eye and Ear Infirmary | 617-573-3313 | cornea_research@meei.harvard.edu |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| OPTI-FREE® RepleniSH® | Drug | Contact Lens care regimen |
|
| Clear Care® | Drug | Contact lens care regimen |
|
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. |
| Six weeks |
| Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea) | The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. | Six weeks |
| Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea) | The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. | Six weeks |
| Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea) | The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. | Six weeks |
| Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea) | The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. | Six weeks |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Protocol Violation |
|
| Physician Decision |
|
| Adverse Event |
|
| BG002 | ReNu MultiPlus® MultiPurpose Solution | 33 participants will be assigned to use this lens care regimen during the six-week assessment period |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | ReNu MultiPlus® MultiPurpose Solution | 33 participants will be assigned to use this lens care regimen during the six-week assessment period |
|
|
| Secondary | Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events | The safety analysis will be based on slit-lamp findings, corrected visual acuity (Snellen) and adverse events (if any). No inferential statistical analyses are planned for any safety variable. | Participants who completed the study visits were analyzed. | Posted | Number | participants | Six weeks | eyes | eyes |
|
|
|
| Primary | Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea) | The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. | Participants who completed the study visits were analyzed. | Posted | Mean | Standard Error | cells/mm2 | Six weeks | eyes | eyes |
|
|
|
| Primary | Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea) | The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. | Participants who completed the study visits were analyzed. | Posted | Mean | Standard Error | cells/mm2 | Six weeks | eyes | eyes |
|
|
|
| Primary | Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea) | The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. | Participants who completed the study visits were analyzed. | Posted | Mean | Standard Error | cells/mm2 | Six weeks | eyes | eyes |
|
|
|
| Primary | Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea) | The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. | Participants who completed the study visits were analyzed. | Posted | Mean | Standard Error | cells/mm2 | Six weeks | eyes | eyes |
|
|
|
| Primary | Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea) | The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. | Participants who completed all visits were analyzed. | Posted | Mean | Standard Error | cells/mm2 | Six weeks | eyes | eyes |
|
|
|
| Primary | Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea) | The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. | Participants who completed all visits were analyzed. | Posted | Mean | Standard Error | cells/mm2 | Six weeks | eyes | eyes |
|
|
|
| Primary | Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea) | The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. | Participants who completed all visits were analyzed. | Posted | Mean | Standard Error | cells/mm2 | Six weeks | eyes | eyes |
|
|
|
| Primary | Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea) | The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. | Participants who completed all visits were analyzed. | Posted | Mean | Standard Error | cells/mm2 | Six weeks | eyes | eyes |
|
|
|
| Primary | Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea) | The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells. | Participants who completed all visits were analyzed. | Posted | Mean | Standard Error | cells/mm2 | Six weeks | eyes | eyes |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Clear Care® | 33 participants will be assigned to use this lens care regimen during the six-week assessment period | 0 | 31 | 1 | 31 |
| EG002 | ReNu MultiPlus® MultiPurpose Solution | 33 participants will be assigned to use this lens care regimen during the six-week assessment period | 0 | 32 | 1 | 32 |
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