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The purpose of this study was to assess and compare the effect of the repeated usage of two different contact lens care systems (one hydrogen peroxide-based cleaning and disinfecting system, and one polyaminopropyl biguanide (PHMB)-containing multipurpose system) with silicone hydrogel contact lenses worn on a daily wear basis for three months. The specific aspect of interest was the effect on the ocular tissue, in particular the eyelids and their associations with the contact lens surface wettability and surface contamination.
The subjects attended the enrollment visit having worn their habitual silicone hydrogel contact lenses for at least six hours on the day of the visit. The enrollment visit was scheduled so that the subjects' habitual lenses were at least 14 ± 3 days old for the subjects replacing their lenses bi-weekly and at least 30 ± 5 days old for those replacing their lenses monthly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLEAR CARE/AOSEPT Plus | Experimental | Hydrogen peroxide-based contact lens care system used per manufacturer's instructions |
|
| ReNu MultiPlus | Active Comparator | PHMB-containing contact lens solution used per manufacturer's instructions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrogen peroxide-based contact lens care system | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Papillae | Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis. | Baseline, Month 3 |
| Maximum Eyelid Hyperaemia | Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis. | Baseline, Month 3 |
| Upper Lid Redness | The contact lenses were removed and upper lid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis. | Baseline, Month 3 |
| Change From Baseline in Upper Eyelid Margin Staining at Month 3 | The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis. | Baseline, Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT) | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Guillon, PhD, FCOptom, FAAO, CCTI | OTG Research & Consultancy | Principal Investigator |
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Of the 79 participants enrolled in the study, 1 participant exited the study between enrollment and product dispensing due to nonavailability. This reporting group includes all enrolled and dispensed participants.
Participants were recruited from one study center located in the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | CLEAR CARE/AOSEPT Plus | Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months |
| FG001 | ReNu MultiPlus | PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This reporting group includes all enrolled and dispensed participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | CLEAR CARE/AOSEPT Plus | Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months |
| BG001 | ReNu MultiPlus |
| 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 | Maximum Papillae | Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis. | All enrolled and dispensed participants who completed the study as per protocol | Posted | Median | Full Range | Units on a scale | Baseline, Month 3 |
|
Adverse events were collected for the duration of the study. The safety population includes all participants exposed to test product.
An adverse event was any untoward medical occurrence in a subject administered a test article, regardless of causal relationship with the treatment.
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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/AOSEPT Plus | Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hysterectomy | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toxic reaction to solution | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Renee Garofalo, OD, FAAO | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D003263 | Contact Lenses, Hydrophilic |
| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| PHMB-containing contact lens solution |
| Device |
|
|
| Soft contact lenses | Device | Contact lenses identical to habitual prescription worn per usual replacement regimen |
|
| Baseline, Month 3 |
| Protective Index | A digital video recording was made of the interblink period. The percentage of area of the visible contact lens covered by the tear film was calculated (Protected Area). The Protective Index is defined as the average tear coverage over the whole interblink period. Both eyes were included in the model for analysis. | Baseline, Month 3 |
| Median Front Lens Deposits | Deposits present on the front surface of the lens were assessed with a biomicroscope while the lens was on eye. Deposits were rated on a 5-point forced choice scale (0 = none; 1 = slight; = mild; 3 = moderate; 4 = severe) in five lens zones. The median of the five zones was used for analysis. Both eyes were included in the model for analysis. | Baseline, Month 3 |
| Total Lipid Uptake Per Lens | The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value would indicate a cleaner lens surface. | Baseline, Month 3 |
PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ReNu MultiPlus |
PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months |
|
|
| Primary | Maximum Eyelid Hyperaemia | Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis. | All enrolled and dispensed participants who completed the study as per protocol | Posted | Median | Full Range | Units on a scale | Baseline, Month 3 |
|
|
|
| Secondary | Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT) | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis. | All enrolled and dispensed participants who completed the study as per protocol | Posted | Mean | Standard Deviation | Seconds | Baseline, Month 3 |
|
|
|
| Primary | Upper Lid Redness | The contact lenses were removed and upper lid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis. | All enrolled and dispensed participants who completed the study as per protocol | Posted | Mean | Standard Deviation | Percentage of total surface measured | Baseline, Month 3 |
|
|
|
| Primary | Change From Baseline in Upper Eyelid Margin Staining at Month 3 | The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis. | All enrolled and dispensed participants who completed the study as per protocol | Posted | Mean | Standard Deviation | square millimeters | Baseline, Month 3 |
|
|
|
| Secondary | Protective Index | A digital video recording was made of the interblink period. The percentage of area of the visible contact lens covered by the tear film was calculated (Protected Area). The Protective Index is defined as the average tear coverage over the whole interblink period. Both eyes were included in the model for analysis. | All enrolled and dispensed participants who completed the study as per protocol | Posted | Mean | Standard Deviation | Percent of visible contact lens surface | Baseline, Month 3 |
|
|
|
| Secondary | Median Front Lens Deposits | Deposits present on the front surface of the lens were assessed with a biomicroscope while the lens was on eye. Deposits were rated on a 5-point forced choice scale (0 = none; 1 = slight; = mild; 3 = moderate; 4 = severe) in five lens zones. The median of the five zones was used for analysis. Both eyes were included in the model for analysis. | All enrolled and dispensed participants who completed the study as per protocol | Posted | Median | Full Range | Units on a scale | Baseline, Month 3 |
|
|
|
| Secondary | Total Lipid Uptake Per Lens | The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value would indicate a cleaner lens surface. | All enrolled and dispensed participants who completed the study as per protocol | Posted | Mean | Standard Deviation | micrograms | Baseline, Month 3 |
|
|
|
| 2 |
| 39 |
| 3 |
| 39 |
| EG001 | ReNu MultiPlus | PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months | 0 | 39 | 0 | 39 |
| Hospitalization | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.