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The purpose of this study is to evaluate the lipid uptake, wetting characteristics, and visual performance of AIR OPTIX® AQUA and ACUVUE® OASYS® with HYDRACLEAR® contact lenses when used in conjunction with two contact lens care systems.
This study will be divided into two phases. In the Pre-Investigational Phase (Phase 1), participants will wear PureVision contact lenses for 30 days and use ReNu® Multiplus® for contact lens care. Eligible participants will continue into the Investigational Phase (Phase 2) and be randomly assigned to wear AIR OPTIX® AQUA contact lenses or ACUVUE® OASYS® with HYDRACLEAR® contact lenses for a total of two months. For contact lens care, participants will use OPTI-FREE® PUREMOIST® MPDS and BIOTRUE® for 30 days each.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Air Optix Aqua | Experimental | Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each |
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| Acuvue Oasys | Active Comparator | Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B contact lenses | Device | Silicone hydrogel contact lenses, Phase 2 |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Ex-Vivo 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 indicates a cleaner lens surface. One eye (study eye) contributed to the mean. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT) | The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jami Kern, PhD | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center at 1-888-451-3937 for Trial Locations | Fort Worth | Texas | 76134 | United States |
Of the 109 participants enrolled, 39 were exited from the study prior to randomization and product dispense (Phase 2). This reporting group includes all randomized and dispensed participants (70).
Participants were recruited from 1 study center located in the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Air Optix Aqua | Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each |
| FG001 | Acuvue Oasys | Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Senofilcon A contact lenses | Device | Silicone hydrogel contact lenses, Phase 2 |
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| OPTI-FREE® PUREMOIST® MPDS | Device | Contact lens care system, Phase 2 |
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| BIOTRUE® | Device | Contact lens care system, Phase 2 |
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| Balafilcon A contact lenses | Device | Silicone hydrogel contact lenses worn for 30 days, Phase 1 |
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| ReNu® Multiplus® | Device | Contact lens care system used for 30 days, Phase 1 |
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| Day 30 |
| LogMAR Time-Controlled Visual Acuity (TCVA) | Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20. | Day 30 |
| Overall Comfort Measured With Visual Analog Scale (VAS) | The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear. | Day 30 |
| Overall Dryness Measured With Visual Analog Scale (VAS) | The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear. | Day 30 |
| Average Exposure Speed | Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean. | Day 30 |
| Minimum Protected Area | Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean. | Day 30 |
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| NOT COMPLETED |
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This analysis population includes all randomized and dispensed participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Air Optix Aqua | Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each |
| BG001 | Acuvue Oasys | Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 Ex-Vivo 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 indicates a cleaner lens surface. One eye (study eye) contributed to the mean. | This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis. | Posted | Geometric Mean | Standard Deviation | micrograms | Day 30 |
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| Secondary | Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT) | The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean. | This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis. | Posted | Geometric Mean | Standard Deviation | seconds | Day 30 |
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| Secondary | LogMAR Time-Controlled Visual Acuity (TCVA) | Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20. | This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy. Two Day 30 measurements per participant contributed to analysis. | Posted | Mean | Standard Deviation | VA unit | Day 30 |
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| Secondary | Overall Comfort Measured With Visual Analog Scale (VAS) | The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear. | This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. | Posted | Mean | Standard Deviation | units on a scale | Day 30 |
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| Secondary | Overall Dryness Measured With Visual Analog Scale (VAS) | The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear. | This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. | Posted | Mean | Standard Deviation | units on a scale | Day 30 |
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| Secondary | Average Exposure Speed | Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean. | This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis. | Posted | Geometric Mean | Standard Deviation | percent of area exposed/second | Day 30 |
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| Secondary | Minimum Protected Area | Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean. | This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis. | Posted | Mean | Standard Deviation | percentage of lens surface covered | Day 30 |
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Adverse events were collected for the duration of the study (December 2012-November 2013).This analysis group includes all participants randomized into the Investigational Phase of the study who participated in at least one period of the study.
An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) 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 | AIR OPTIX AQUA | Lotrafilcon B contact lenses worn for 60 days, replaced monthly | 0 | 34 | 3 | 34 | ||
| EG001 | ACUVUE OASYS With HYDRACLEAR | Senofilcon A contact lenses worn for 60 days, replaced biweekly | 0 | 36 | 7 | 36 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Eye complication associated with device | General disorders | MedDRA 15.1 | Systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessie Lemp, DrPH | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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