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The purpose of this study is to evaluate the performance of two commercially marketed daily disposable contact lenses in a population of daily disposable contact lens wearers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nelfilcon A / Narafilcon B | Other | Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week. |
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| Narafilcon B / Nelfilcon A | Other | Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfilcon A contact lens | Device | Commercially marketed, spherical contact lens for daily wear, daily disposable use |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Vision Quality | Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. | 1 week of wear |
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Inclusion Criteria:
Exclusion Criteria:
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This reporting group includes all enrolled and dispensed participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nelfilcon A / Narafilcon B | Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week. |
| FG001 | Narafilcon B / Nelfilcon A | Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, One Week |
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| Period 2, One Week |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | This reporting group includes all enrolled and dispensed participants. |
| 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 | Overall Vision Quality | Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. | Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | units on a scale | 1 week of wear |
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Adverse event data were collected for the duration of the trial: 41 days.
This reporting group includes all enrolled and exposed subjects.
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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 | Commercially marketed, spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joe Rappon, OD, MS, FAAO / Head, Clinical Trial Management | CIBA VISION | 1-678-415-3343 | Joseph.Rappon@cibavision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Narafilcon B contact lens | Device | Commercially marketed (US), spherical contact lens for daily wear, daily disposable use |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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Commercially marketed (US), spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week. |
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|
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Narafilcon B | Commercially marketed (US), spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week. | 0 | 60 | 0 | 60 |
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 discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.