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| Name | Class |
|---|---|
| University of Manchester | OTHER |
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This study seeks to evaluate the impact of wearing a new daily disposable soft contact lens on the neophyte population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| spectacles | Other | habitual spectacles worn daily for 12 months |
|
| narafilcon A soft contact lenses | Experimental | narafilcon A soft contact lenses worn as daily disposable for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spectacles | Device | habitual spectacles |
| |
| narafilcon A soft contact lenses |
| Measure | Description | Time Frame |
|---|---|---|
| Papillary Conjunctivitis | Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis. | Comprised of 8 categories (conjunctival hyperemia, limbal hyperemia, corneal vascularization, microcysts, Oedema, corneal staining, conjunctival staining and papillary conjunctivitis) each scored on a scale of 0 to 4 where 0=none, and 4=maximum score for each category. | at 12 months |
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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 | Manchester | Greater Manchester | M60 1QD | United Kingdom |
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There were 74 subjects enrolled into the study, 38 into the TruEye group and 36 in the spectacle group. Forty-eight subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spectacles | spectacles worn daily for 12 months |
| FG001 | Narafilcon A Lenses | narafilcon A soft contact lenses worn as daily disposable for 12 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
There were 74 subjects enrolled with 48 completing the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Spectacles | spectacles worn daily for 12 months |
| BG001 | Narafilcon A Lenses | narafilcon A soft contact lenses worn as daily disposable for 12 months |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis. | Comprised of 8 categories (conjunctival hyperemia, limbal hyperemia, corneal vascularization, microcysts, Oedema, corneal staining, conjunctival staining and papillary conjunctivitis) each scored on a scale of 0 to 4 where 0=none, and 4=maximum score for each category. | Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study. | Posted | Mean | Standard Deviation | units on a scale | at 12 months |
|
Throughout the entire duration of the sutdy. Approximately 12 month.
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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 | Spectacles | spectacles worn daily for 12 months | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-signficant Corneal Event | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathy Osborn, OD | Johnson & Johnson Vision Care, Inc. | +1 904 443-1032 | clinicalstudies@its.jnj.com |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Device |
narafilcon A daily disposable contact lenses |
|
| Visual Acuity After 12 Months of Wear | Visual acuity is measured at high and low contrasts, via the Snellen scale which is then mathematically converted to logMar units. High contrast refers to a darker print on the Snellen chart and is an easier testing environment compared to the low contrast which has a grayer print. | at 12 months |
| Subjective Overall Comfort After 12 Months of Daily Wear | subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort | at 12 months |
| Subjective Overall Vision After 12 Months of Daily Wear | subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision | at 12 months |
| Pregnancy |
|
| Poor vision |
|
| Visit out of range at month 12 |
|
| Did not meet protocol criteria |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
habitual spectacles worn daily for 12 months
|
|
| Secondary | Visual Acuity After 12 Months of Wear | Visual acuity is measured at high and low contrasts, via the Snellen scale which is then mathematically converted to logMar units. High contrast refers to a darker print on the Snellen chart and is an easier testing environment compared to the low contrast which has a grayer print. | Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study. | Posted | Mean | Standard Deviation | logMar | at 12 months |
|
|
|
| Secondary | Subjective Overall Comfort After 12 Months of Daily Wear | subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort | Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study. | Posted | Mean | Standard Deviation | units on a scale | at 12 months |
|
|
|
| Secondary | Subjective Overall Vision After 12 Months of Daily Wear | subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision | Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study. | Posted | Mean | Standard Deviation | units on a scale | at 12 months |
|
|
|
| Primary | Papillary Conjunctivitis | Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns. | Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| 36 |
| 0 |
| 36 |
| 5 |
| 36 |
| EG001 | Narafilcon A Lenses | narafilcon A soft contact lenses worn as daily disposable for 12 months | 0 | 38 | 0 | 38 | 4 | 38 |
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