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The purpose of this study is to validate the improvements to the inversion indicator.
This study was conducted in three countries under three separate protocols: P-346-C-009 sub 02 (UK), P-346-C-009 sub 03 (Germany), and P-346-C-010 (USA). The data reported represents pooled data from the three protocols.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nelfilcon A, modified inversion indicator | Experimental | Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week |
|
| nelfilcon A, no inversion indicator | Experimental | Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week |
|
| nelfilcon A, inversion indicator | Active Comparator | Nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nelfilcon A contact lens, modified inversion indicator | Device | Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with modified inversion indicator |
| Measure | Description | Time Frame |
|---|---|---|
| Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion. | As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, "Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion?" The positive "yes" responses are reported. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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This reporting group includes all enrolled and dispensed participants. Note: One subject was enrolled but not dispensed due to failing inclusion/exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nelfilcon A, Modified Inversion Indicator | nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week |
| FG001 | Nelfilcon A, No Inversion Indicator | nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week |
| FG002 | Nelfilcon A, Inversion Indicator | nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nelfilcon A, Modified Inversion Indicator | nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week |
| BG001 | Nelfilcon A, No Inversion Indicator |
| 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 | Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion. | As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, "Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion?" The positive "yes" responses are reported. | Analysis conducted per protocol, with exclusions due to protocol deviations as determined by masked review (9), and unavailable data due to discontinuations (3). | Posted | Number | participants | 1 week |
|
Adverse event data was collected for the duration of the trial: 78 days
This reporting group includes all enrolled and exposed participants: 280
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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 | Nelfilcon A, Modified Inversion Indicator | nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other contact lens symptoms not requiring treatment | Eye disorders | Systematic Assessment | Participants reported on a questionnaire the nature, frequency and severity of any/all lens-related symptoms experienced with lens wear. Any frequency and/or severity significantly higher with study lenses than with habitual was an adverse event. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs | CIBA VISION | 1-800-241-7629 | priya.janakiraman@cibavision.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| nelfilcon A contact lens, no inversion indicator | Device | Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with no inversion indicator |
|
| nelfilcon A contact lens, inversion indicator | Device | Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear, with inversion indicator |
|
|
nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
| BG002 | Nelfilcon A, Inversion Indicator | nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Nelfilcon A, No Inversion Indicator |
nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week |
| OG002 | Nelfilcon A, Inversion Indicator | nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week. |
|
|
| 0 |
| 90 |
| 6 |
| 90 |
| EG001 | Nelfilcon A, No Inversion Indicator | nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week | 0 | 98 | 13 | 98 |
| EG002 | Nelfilcon A, Inversion Indicator | nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week. | 0 | 92 | 13 | 92 |
|
For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussion, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.