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The purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of neophytes (new wearers).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nelfilcon A | Experimental | Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week. |
|
| narafilcon A | Active Comparator | Commercially marketed contact lens 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 | Device | Commercially marketed, hydrogel, single-vision contact lens for daily wear, daily disposable use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Lens Satisfaction | Overall Lens Satisfaction, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being Poor and 10 being Excellent | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Research Intelligence Group (TRiG) | Fort Washington | Pennsylvania | 19034 | United States |
Twenty-seven participants were enrolled but not dispensed. These participants were included in the Actual Enrollment calculation, but not in Participant Flow or Baseline Characteristics calculations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nelfilcon A | Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week. |
| FG001 | Narafilcon A | Commercially marketed contact lens 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 | Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week. |
| BG001 | Narafilcon A | Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week. |
| 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 Lens Satisfaction | Overall Lens Satisfaction, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being Poor and 10 being Excellent | Analysis conducted per protocol, with exclusions due to major protocol deviations as determined by masked review, discontinuations, and/or missing responses. | Posted | Mean | Standard Deviation | Units on a Scale | 1 week |
|
Adverse event data were collected for the duration of the trial: 108 days.
This reporting group includes all enrolled and exposed participants.
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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 contact lens worn in both eyes on a daily wear, daily disposable basis for one week. |
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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 |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| narafilcon A contact lens | Device | Commercially marketed, silicone hydrogel, single-vision contact lens for daily wear, daily disposable use. |
|
| Discomfort |
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| Biomicroscopy |
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| Influenza |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
|
|
| 0 |
| 151 |
| 0 |
| 151 |
| EG001 | Narafilcon A | Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week. | 0 | 163 | 0 | 163 |
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.