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| Name | Class |
|---|---|
| University of Manchester | OTHER |
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This study seeks to evaluate the clinical performance of a recently improved daily disposable contact lens to an established daily disposable contact lens that contains a wetting agent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A first nelfilcon A second | Other | etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2 |
|
| nelfilcon A first, etafilcon A second | Other | nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device | contact lens worn daily for one week (first or second week depending on arm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination. | 2-week |
| Subjective Lens Comfort | Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used. | 2-week |
| Measure | Description | Time Frame |
|---|---|---|
| Subject-reported Overall Product Performance | Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience | Manchester | M60 1QD | United Kingdom |
Sixty subjects enrolled and sixty subjects completed.
Sixty subjects were enrolled onto the study to wear contact lenses for two weeks on a daily wear basis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A/Nelfilcon A | etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2. |
| FG001 | Nelfilcon A/Etafilcon A | nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Baseline to One-week |
| |||||||||||||
| Period 2: One-week to Two-weeks |
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Subjects are those who were enrolled and randomized to a study arm. Sixty subjects were enrolled and sixty subjects completed.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects crossed over to use each treatment for one week |
| 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 | Visual Acuity | Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination. | Subjects analyzed are those who were enrolled, randomized to a study arm, and completed the study. | Posted | Mean | Standard Deviation | logMAR scale | 2-week |
|
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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 | Etafilcon A First Nelfilcon A Second | etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kurt Moody, OD | Johnson & Johnson Vision Care | +1 904 443-3088 | kmoody1@its.jnj.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| nelfilcon A | Device | Contact lens worn daily for one week (first or second week depending on arm) |
|
|
| 2-week |
| Optimum Lens Fit | Number of subjects that measured as an optimum fit. Lens fit will be assessed using the following evaluations: horizontal and vertical centration, corneal coverage and movement. Normally, for an acceptable fit, centration and movement will fall within currently accepted clinical criteria [between -1 and +1 on a -2 to +2 grading scale.](streamdown:incomplete-link) | Baseline, 1-week, 2-week |
| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Subject-reported Overall Product Performance | Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used. | Analyzed subjects were those who were enrolled and randomized to a study arm. | Posted | Least Squares Mean | Standard Error | units on a scale | 2-week |
|
|
|
| Secondary | Optimum Lens Fit | Number of subjects that measured as an optimum fit. Lens fit will be assessed using the following evaluations: horizontal and vertical centration, corneal coverage and movement. Normally, for an acceptable fit, centration and movement will fall within currently accepted clinical criteria [between -1 and +1 on a -2 to +2 grading scale.](streamdown:incomplete-link) | Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study. | Posted | Number | participants | Baseline, 1-week, 2-week |
|
|
|
| Primary | Subjective Lens Comfort | Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used. | Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study. | Posted | Least Squares Mean | Standard Deviation | units on a scale | 2-week |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Nelfilcon A First Etafilcon A Second | nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2 | 0 | 60 | 0 | 60 |
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