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The purpose of this study is to evaluate AIR OPTIX® plus HYDRAGLYDE® (AOHG) contact lenses compared to AIR OPTIX® AQUA (AOA) contact lenses in overall lens fit.
Subjects must not wear any contact lenses prior to the visit on Day 1 (Insertion) for Period 1 or Day 1 (Insertion) for Period 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AOHG, then AOA | Other | Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution. |
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| AOA, then AOHG | Other | Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B contact lenses with EOBO-41 | Device | Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Satisfying the "no Re-fit" Criteria in Both Eyes | Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved. | Day 30, each product |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear | The contact lens was removed from the eye. Cholesterol deposits were extracted and measured in micrograms (μg) per lens. Lower deposits indicate increased lens performance. Only one eye (right eye) contributed to the analysis. | Day 30, each product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Manager, EMEA | Alcon, A Novartis Division | Study Director |
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Of the 82 enrolled, 6 subjects were exited as screen failures prior to randomization. One subject withdrew consent after randomization, but before exposure to product. This reporting group includes all randomized and exposed subjects (75).
Subjects were recruited from 1 study center located in the United Kingdom (UK).
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| ID | Title | Description |
|---|---|---|
| FG000 | AOHG, Then AOA | Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution. |
| FG001 | AOA, Then AOHG |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1, First 30 Days of Wear |
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| Lotrafilcon B contact lenses | Device | Lotrafilcon B contact lenses packaged with copolymer 845 |
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| Hydrogen peroxide-based lens care solution | Device | Commercially-available hydrogen peroxide-based lens care solution for cleaning, disinfecting, and storing silicone hydrogel soft contact lenses |
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| Saline solution for rinsing contact lenses | Device | Commercially-available saline solution used as needed |
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| Saline solution for rinsing contact lens case | Device | Commercially-available solution used as needed |
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| Change From Insertion in Minimum Protected Area (MPA) |
MPA (the minimum area of the contact lens surface (expressed in %) protected by the tear film between two natural blinks) was assessed by the Investigator during the interblink period using the Tearscope® lighting system. Higher values indicate a more stable tear film in front of the lens. This Outcome Measure was pre-specified for AOHG only. Both eyes contributed to the analysis. |
| Hour 0 (Lens Insertion) to Hour 12 on Day 1 |
Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution. |
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| NOT COMPLETED |
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| Period 2, Second 30 Days of Wear |
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This analysis population includes all randomized and exposed subjects (Full Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Lotrafilcon B contact lenses with EOBO-41 and lotrafilcon B contact lenses worn bilaterally during Period 1 and Period 2 in a crossover assignment, as randomized. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||||||||||||||||||||||
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| Primary | Percentage of Subjects Satisfying the "no Re-fit" Criteria in Both Eyes | Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved. | Full Analysis Set. Number Analyzed is the number of subjects with non-missing response. | Posted | Number | percentage of subjects | Day 30, each product |
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| Secondary | Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear | The contact lens was removed from the eye. Cholesterol deposits were extracted and measured in micrograms (μg) per lens. Lower deposits indicate increased lens performance. Only one eye (right eye) contributed to the analysis. | Full Analysis Set. Only the right (OD) lenses were collected from a subset of subjects. | Posted | Mean | Standard Deviation | μg | Day 30, each product |
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| Secondary | Change From Insertion in Minimum Protected Area (MPA) | MPA (the minimum area of the contact lens surface (expressed in %) protected by the tear film between two natural blinks) was assessed by the Investigator during the interblink period using the Tearscope® lighting system. Higher values indicate a more stable tear film in front of the lens. This Outcome Measure was pre-specified for AOHG only. Both eyes contributed to the analysis. | Full Analysis Set. Number Analyzed is the number of eyes with non-missing response. | Posted | Mean | Standard Deviation | percentage of contact lens surface area | Hour 0 (Lens Insertion) to Hour 12 on Day 1 | Eyes | Eyes |
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Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 74 days). AEs are reported as pre-treatment and treatment-emergent.
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 | Pretreatment | All subjects who consented to participate in the study prior to initiation of study treatment | 0 | 82 | 0 | 82 | 0 | 82 |
| EG001 | AOHG Contact Lenses | All subjects exposed to AOHG contact lenses | 0 | 75 | 1 | 75 | 0 | 75 |
| EG002 | AOA Contact Lenses | All subjects exposed to AOA contact lenses | 0 | 75 | 0 | 75 | 0 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Food Poisoning | Gastrointestinal disorders | MedDRA (17.0) |
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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 | |
|---|---|---|---|---|
| Sr. Global Brand Medical Affairs Lead, GCRA | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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