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A comparative evaluation of a newly marketed multifocal contact lens with a single vision contact lens when used with near vision spectacles. The evaluation was to quantify the difference between the two test corrections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (sphere) /Test (multi-focal) | Other | Subjects were first fitted with Control lens (sphere) and a pair of reading glasses for one week. Subjects were then fitted with the Test lens (multi-focal) for one week. |
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| Test (sphere) /Control (multi-focal) | Other | Subjects were first fitted with the Test lens (multi-focal) for one week. Subjects were then fitted with Control lens (sphere) and a pair of reading glasses for one week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test (multi-focal) | Device | contact lens was to be worn a daily wear. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance LogMAR Visual Acuity | Distance time controlled LogMAR (Logarithm of the Minimum Angle of Resolution) Visual Acuity was carried out binocularly, at 4m (meter) under 250 cd/m^2 and 2.5 cd/m^2 (candela per square meter) luminance. The test was presented under the two conditions; High luminance (250 cd/m^2) High Contrast (90%) & Low Contrast (10%) and Low Luminance (2.5 cd/m^2) High Contrast (90%) | 7 days post wear |
| Near LogMAR Visual Acuity | Near time controlled LogMAR Visual Acuity was carried out binocularly, at 4cm under 250 cd/m^2 and 50 cd/m^2 luminance. The test was presented on under the two conditions; High Luminance (250cd/m^2) High Contrast (90%) & Low Contrast (10%) and Low Luminance (50cd/m^2) High Contrast (90%) | 7 days post wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London | SW1E6AU | United Kingdom |
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A total of 41 subjects were enrolled in this study. Of the enrolled subjects 1 did not meet the eligibility criteria and 40 subjects were dispensed a study lens. Of the dispensed subjects, 3 were discontinued and 37 subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control (Filcon II 3- Sphere) /Test (Filcon II 3-multi-focal) | Subjects were first fitted with the Control lens (filcon II 3- sphere) and a pair of reading glasses for one week. Subjects were then fitted with the Test lens (filcon II 3-multi-focal) for one week. |
| FG001 | Test (Filcon II 3-multi-focal) /Control (Filcon II 3- Sphere) | Subjects were first fitted with the Test lens (filcon II 3-multi-focal) for one week. Subjects were then fitted with Control lens (filcon II 3- sphere) and a pair of reading glasses for one week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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All subjects that were randomized to one of two lens wear serquences.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control (Filcon II 3-sphere) /Test (Filcon II 3-multi-focal) | All subjects that were randomized to sequence and were dispensed a study lens. |
| BG001 | Test (Filcon II 3-multi-focal) / Control (Filcon II 3-spher) |
| 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 | Distance LogMAR Visual Acuity | Distance time controlled LogMAR (Logarithm of the Minimum Angle of Resolution) Visual Acuity was carried out binocularly, at 4m (meter) under 250 cd/m^2 and 2.5 cd/m^2 (candela per square meter) luminance. The test was presented under the two conditions; High luminance (250 cd/m^2) High Contrast (90%) & Low Contrast (10%) and Low Luminance (2.5 cd/m^2) High Contrast (90%) | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | LogMAR | 7 days post wear |
|
Throughout duration of the study(approximately 4 months).
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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 | Control (Filcon II 3-sphere) | Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tom Karkkainen, OD, MS, FAAO | Johnson & Johnson Vision Care INC. | 904-443-3500 | 3402 | TKarkkai@its.jnj.com |
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| Control (Sphere) | Device | contact lens was to be worn a daily wear with spectacles |
|
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| NOT COMPLETED |
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All subjects that were randomized to sequence and were dispensed a study lens.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study. |
|
|
| Primary | Near LogMAR Visual Acuity | Near time controlled LogMAR Visual Acuity was carried out binocularly, at 4cm under 250 cd/m^2 and 50 cd/m^2 luminance. The test was presented on under the two conditions; High Luminance (250cd/m^2) High Contrast (90%) & Low Contrast (10%) and Low Luminance (50cd/m^2) High Contrast (90%) | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | LogMAR | 7 days post wear |
|
|
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| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Test (Filcon II 3-multi-focal) | Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study. | 0 | 40 | 0 | 40 |
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| High Contrast-Near-Standard Low Luminance |
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