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The purpose of this study is to evaluate differences in the comfort at the end of the month between Air Optix® lenses versus Biofinity® lenses in habitual daily wear symptomatic soft contact lens wearers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Air Optix | Experimental | Lotrafilcon B contact lenses worn bilaterally (in both eyes) for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis (removed nightly for cleaning and disinfection). |
|
| Biofinity | Active Comparator | Comfilcon A contact lenses worn bilaterally (in both eyes) for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis (removed nightly for cleaning and disinfection). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B contact lenses | Device | Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30 | Overall comfort was assessed by the participant as a response to the questionnaire item 'I can comfortably wear my lenses', using a 10-point Likert scale, with 1=poor and 10=excellent. | Baseline, Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jami Kern, Ph.D. | Alcon Research | Study Director |
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Of the 398 enrolled, 17 participants were exited as screen failures. This reporting group includes all participants who provided informed consent, were randomized, and utilized the study lenses (381).
Participants were recruited from 22 sites located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Air Optix | Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis |
| FG001 | Biofinity | Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This analysis population includes all randomized participants who utilized the study lenses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Air Optix | Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis |
| BG001 | Biofinity | Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 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 | Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30 | Overall comfort was assessed by the participant as a response to the questionnaire item 'I can comfortably wear my lenses', using a 10-point Likert scale, with 1=poor and 10=excellent. | This analysis population includes all participants who completed the protocol and had no major protocol violations. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 30 |
|
Adverse events (AEs) were collected from 10 Jul 2013 to 20 Nov 2013. AEs were obtained through volunteered and elicited comments from the participants.
An AE 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. This analysis population includes all participants enrolled and exposed to test and control articles.
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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 | Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acanthamoeba keratitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessie Lemp, GMA Affairs Lead | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Comfilcon A contact lenses | Device | Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription |
|
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| Adverse Event |
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| Investigator decision |
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| Poor comfort of study lenses |
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| Subject decision unrelated to AE |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 1 |
| 193 |
| 0 |
| 193 |
| EG001 | Biofinity | Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis | 1 | 188 | 0 | 188 |
| Chest pain | General disorders | MedDRA (16.0) | Non-systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.