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The purpose of this study was to assess and compare the effect of the repeated usage of 2 different care systems (one hydrogen peroxide based cleaning and disinfecting system and one PHMB containing multipurpose system) with ACUVUE® 2® and AIR OPTIX® AQUA contact lenses worn on a daily wear basis for a 3-month period.
This study was divided into 2 periods, a Screening Phase and an Investigational Phase. During the Screening Phase, subjects were fitted and dispensed with either ACUVUE® 2® (for current hydrogel wearers) or AIR OPTIX® AQUA (for current silicone hydrogel wearers) contact lenses and used COMPLETE® MPS Easy Rub® Formula to clean and disinfect their lenses. At the completion of the Screening Phase, the symptomatic status of the subjects was re-assessed. Those subjects who qualified proceeded to the Investigational Phase and were dispensed with new pair of study contact lenses identical to the lenses they wore during the Screening Phase to use in conjunction with the allocated study care product, CLEAR CARE® /AOSEPT® Plus or ReNu MultiPlus®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AOSEPT Plus | Experimental | AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase) |
|
| ReNu MultiPlus | Active Comparator | ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase) |
|
| Complete MPS Easy Rub | Other | COMPLETE® MPS Easy Rub® Formula contact lens solution used with etafilcon A contact lenses (14 days) or lotrafilcon B contact lenses (30 days), Screening Phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AOSEPT® Plus contact lens solution | Device | Hydrogen peroxide-based cleaning and disinfection system |
|
| 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. Contact lenses were not worn for this assessment. | Baseline (Day 0), 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. Contact lenses were not worn for this assessment. | Baseline (Day 0), Month 3 |
| Mean Upper Eyelid Redness | The contact lenses were removed and upper eyelid 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. Contact lenses were not worn for this assessment. | Baseline (Day 0), Month 3 |
| Mean Upper Eyelid Margin Staining | 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. Contact lenses were not worn for this assessment. | Baseline (Day 0), 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. Contact lenses were on-eye for this assessment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renee Garofalo, OD, FAAO | Alcon Research | Study Director |
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Of the 100 participants enrolled, 21 were exited as screen failures prior to initiation of the Investigational Phase. This reporting group includes all participants randomized into the Investigational Phase (79).
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| ID | Title | Description |
|---|---|---|
| FG000 | AOSEPT Plus | AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase) |
| FG001 | ReNu MultiPlus | ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This analysis population includes all participants who completed the study as per the protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | AOSEPT Plus | AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase) |
| 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. Contact lenses were not worn for this assessment. | This analysis population includes all participants who completed the study as per the protocol, minus missing responses. | Posted | Median | Full Range | Units on a scale | Baseline (Day 0), Month 3 | Eyes | Participants |
|
Adverse events were collected for the duration of the study (April 2012 to June 2013). An adverse event was any untoward medical occurrence in a subject administered a test article regardless of causal relationship with the treatment.
This analysis population includes all participants exposed to the test product during the Investigational Phase.
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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 | AOSEPT Plus | AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall causing crack on the skull and internal bleeding | Injury, poisoning and procedural complications |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toxic reaction | Injury, poisoning and procedural complications |
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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 |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ReNu MultiPlus® contact lens solution | Device | Polyaminopropyl biguanide (PHMB) preserved multipurpose solution |
|
| Etafilcon A contact lenses | Device | Hydrogel contact lenses worn on a daily wear basis for 14 days (Screening Phase) and 3 months (Investigational Phase). During the Investigational Phase, the contact lenses lenses were worn a minimum of six hours per day, 5 days per week, with a fresh pair dispensed every 2 weeks. |
|
|
| Lotrafilcon B contact lenses | Device | Silicone hydrogel contact lenses worn on a daily wear basis for 30 days (Screening Phase) and 3 months (Investigational Phase). During the Investigational Phase, the contact lenses lenses were worn a minimum of six hours per day, 5 days per week, with a fresh pair dispensed monthly. |
|
|
| COMPLETE® MPS Easy Rub® Formula contact lens solution | Device | PHMB 0.0001% and poloxamer 0.05% multipurpose solution |
|
| Month 3 |
ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | ReNu MultiPlus | ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase) |
|
|
| 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. Contact lenses were not worn for this assessment. | This analysis population includes all participants who completed the study as per the protocol, minus missing responses. | Posted | Median | Full Range | units on a scale | Baseline (Day 0), Month 3 | Eyes | Participants |
|
|
|
| Primary | Mean Upper Eyelid Redness | The contact lenses were removed and upper eyelid 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. Contact lenses were not worn for this assessment. | This analysis population includes all participants who completed the study as per the protocol, minus missing responses. | Posted | Mean | Standard Deviation | percentage of total surface measured | Baseline (Day 0), Month 3 | Eyes | Participants |
|
|
|
| Primary | Mean Upper Eyelid Margin Staining | 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. Contact lenses were not worn for this assessment. | This analysis population includes all participants who completed the study as per the protocol, minus missing responses. | Posted | Mean | Standard Deviation | square millimeters | Baseline (Day 0), Month 3 | Eyes | Participants |
|
|
|
| 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. Contact lenses were on-eye for this assessment. | This analysis population includes all participants who completed the study as per the protocol, minus missing responses. | Posted | Mean | Standard Deviation | seconds | Month 3 | Eyes | Participants |
|
|
|
| 2 |
| 39 |
| 3 |
| 39 |
| EG001 | ReNu MultiPlus | ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase) | 2 | 39 | 0 | 39 |
| Fibroids | Surgical and medical procedures |
|
| Hernia | Surgical and medical procedures |
|
| Dehydration and possible chest infection | Surgical and medical procedures |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.