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The purpose of this study is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nelfilcon A / ocufilcon D | Other | Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. |
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| ocufilcon D / nelfilcon A | Other | Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nelfilcon A contact lens | Device | Commercially marketed, toric, soft contact lens for daily disposable wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort | Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured 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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Three participants were enrolled but not dispensed due to failing inclusion/exclusion criteria. These participants were included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nelfilcon A / Ocufilcon D | Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. |
| FG001 | Ocufilcon D / Nelfilcon A | Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, 1 Week of Wear |
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| Period 2, 1 Week of Wear |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | This reporting group includes all enrolled and dispensed subjects |
| 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 | Overall Comfort | Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured 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 |
|
Adverse event data were collected for the duration of the trial = 87 days. Individual exposure = 2 weeks (1 week per product)
All enrolled and exposed participants. Common lens-related symptoms were collected at baseline. Any 3-grade change (1 or more symptoms) from baseline in frequency or severity was recorded as an adverse event. Frequency was collected on a 5-point scale, with 0=never and 4=always. Severity was collected on a 5-point scale, with 0=none and 4=severe.
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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, toric, soft contact lens for daily disposable wear |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 3-grade change in symptoms (frequency and/or severity) from baseline | Eye disorders | Systematic Assessment | As collected on a questionnaire. Symptoms included 1 or more of the following: lens awareness, discomfort, blurred vision. |
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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 |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ocufilcon D contact lens | Device | Commercially marketed, toric, soft contact lens for daily disposable wear |
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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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| 0 |
| 217 |
| 16 |
| 217 |
| EG001 | Ocufilcon D | Commercially marketed, toric, soft contact lens for daily disposable wear | 0 | 216 | 27 | 216 |
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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.