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This is a single-visit prospective study to establish a real world Marketed Contact Lens 'Through Focus Curve' (TFC) measurement by comparing the consistency of vision between myopes and hyperopes. 33 subjects will be enrolled (at least 15 myopes and 15 hyperopes), who are 40 years of age or older, for a 1-visit, 4-hour study for measurements to be taken.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Lens (etafilcon A) for Multifocal | Experimental | All Subjects in this study will wear the same contact lenses. However subjects wil be stratified as Hyperopes or Myopes using a 1:1 allocation. The study lens will be worn for a period of approximately 4 hours to allow lenses to settle on the eyes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device | Marketed Multifocal Contact Lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance Binocular LogMAR Visual Acuity | Distance Binocular LogMAR Visual Acuity was measured at 4m for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 ) | 4 Hr. Post Fitting |
| Near Binocular LogMAR Visual Acuity | Near Binocular LogMAR Visual Acuity was measured at 40cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 ) | 4 Hr. Post Fitting |
| Intermediate Binocular LogMAR Visual Acuity | intermediate Binocular LogMAR Visual Acuity was measured at 67cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 ) | 4 Hr. Post Fitting |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optometry Technology Group, Ltd. | London | SW1E 6AU | United Kingdom |
A total of 30 subjects were enrolled into this study. Subjects were stratified as either Hyperope or Myopes using a 1:1 allocation. All enrolled subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A (Multi-focal) | All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects that were dispensed a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etafilcon A (Multi-focal) | All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power. |
| 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 Binocular LogMAR Visual Acuity | Distance Binocular LogMAR Visual Acuity was measured at 4m for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 ) | The analysis population includes all subjects that completed the study without a major protocol deviation. | Posted | Mean | Standard Deviation | -10*LogMAR | 4 Hr. Post Fitting |
|
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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 (Multi-focal) | All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tom Karkkainen SR. PRINCIPAL RESEARCH OPTOMETRIST | Johnson & Johnson Vision Care Inc. | 904-443-3500 | 3402 | TKarkkai@its.jnj.com |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Primary | Near Binocular LogMAR Visual Acuity | Near Binocular LogMAR Visual Acuity was measured at 40cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 ) | The analysis population includes all subjects that completed the study without a major protocol deviation. | Posted | Mean | Standard Deviation | -10*LogMAR | 4 Hr. Post Fitting |
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|
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| Primary | Intermediate Binocular LogMAR Visual Acuity | intermediate Binocular LogMAR Visual Acuity was measured at 67cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 ) | The analysis population includes all subjects that completed the study without a major protocol deviation. | Posted | Mean | Standard Deviation | -10*LogMAR | 4 Hr. Post Fitting |
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| 0 |
| 30 |
| 0 |
| 30 |
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| High Luminance; N=16, N=14 |
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| High Luminance; N=16, N=14 |
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