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This is a four week study to evaluate the performance of a multifocal contact lens in habitual wearers of silicone hydrogel multifocal contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifocal Test Contact Lens | Experimental | Subjects will wear the etafilcon A Multifocal test lens in a daily wear modality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A MULTIFOCAL | Device | Subjects will wear the test lens for four weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Total Grade of Conjunctival Hyperemia | Hyperemia (Redness) was assessed using two different parts of the eye, the Bulbar and the Limbal. Hypemeria was measured using the Efron Scale in 0.5 step units. Grade 0= No Findings, Grade 1= Slight, Grade 2= Mild , Grade 3= Moderate and Grade 4 = severe. Hypermia was assessed in four regions of the eye (Inferior, Nasal, Temporal and Superior). The total grade of Conjunctival Hypermia across all regions and grades is reported. The total grade can range from 0 to 8. Where a higher grade implies worsening conjunctival hypermia | Baseline to 4-Week Follow-up |
| Upper Lid Margin Staining Score | Upper Lid Margin Staining was assessed using Fluorescein Staining and was measured on the Graded Scale is Grade 0: No Staining is present, Grade 1= 1% to 25% Stains, Grade 2= 26% to 50% Stains, Grade 3= 51% to 75% Stains, Grade 4 76% to 100% Stains. The percentage of eyes with upper lid margin staining for each Grade is reported. | Baseline to 4-Week Follow-up |
| Average Corneal Staining Area Grade | Corneal staining Area Grade was assessed in throughout five (5) regions in the eye (Central, Nasal, Temporal, Inferior, Superior). Corneal Staining was Graded using the Efron scale from 0 to 4 in 0.1 unit steps and converted to a percentage of region that was stained. The average percent of region that was stained was calculated and reported. | Baseline to 4- Week Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Waterloo | Ontario | N2L 3G1 | Canada |
Forty-four (44) subjects were enrolled in this study. Five (5) subjects did not meet the eligibility and were not dispensed a study article. Of the 39 subjects dispensed study lenses all subjects completed the study without any major protocol deviations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Multi-focal(Etafilcon A) | All subjects worn the Test Contact Lens, Multi-focal (etafilcon A) as daily wear modality over a period of four weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects that were dispensed a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Multi-focal(Etafilcon A) | All subjects wore the Test Contact Lens, Multi-focal (etafilcon A) as a daily wear modality over a period of four weeks. |
| 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 | The Total Grade of Conjunctival Hyperemia | Hyperemia (Redness) was assessed using two different parts of the eye, the Bulbar and the Limbal. Hypemeria was measured using the Efron Scale in 0.5 step units. Grade 0= No Findings, Grade 1= Slight, Grade 2= Mild , Grade 3= Moderate and Grade 4 = severe. Hypermia was assessed in four regions of the eye (Inferior, Nasal, Temporal and Superior). The total grade of Conjunctival Hypermia across all regions and grades is reported. The total grade can range from 0 to 8. Where a higher grade implies worsening conjunctival hypermia | The analysis population consists of all subjects that completed all study visits without a major protocol deviation. The analysis is conducted on subject eyes. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 4-Week Follow-up | Subject Eyes | Subject Eyes |
|
Throughout the duration of the study- Approximately 7 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 | Multi-focal(Etafilcon A) | All subjects worn the Test Contact Lens, Multi-focal (etafilcon A) as daily wear modality over a period of four weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tom Karkkainen O.D., M.S., F.A.A.O- Sr. Research Principal Optometrist | Johnson & Johnson Vision Care Inc. | 904-443-3500 | 3402 | TKarkkai@its.jnj.com |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | Participants |
|
| OG001 | Multi-focal(Etafilcon A) | All subjects wore the study lens, Multi-focal (etafilcon A ) as daily wear modality over a period of four weeks. |
|
|
| Primary | Upper Lid Margin Staining Score | Upper Lid Margin Staining was assessed using Fluorescein Staining and was measured on the Graded Scale is Grade 0: No Staining is present, Grade 1= 1% to 25% Stains, Grade 2= 26% to 50% Stains, Grade 3= 51% to 75% Stains, Grade 4 76% to 100% Stains. The percentage of eyes with upper lid margin staining for each Grade is reported. | The analysis population consists of all subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes. | Posted | Number | percentage of eyes | Baseline to 4-Week Follow-up | Subject Eyes | Subject Eyes |
|
|
|
| Primary | Average Corneal Staining Area Grade | Corneal staining Area Grade was assessed in throughout five (5) regions in the eye (Central, Nasal, Temporal, Inferior, Superior). Corneal Staining was Graded using the Efron scale from 0 to 4 in 0.1 unit steps and converted to a percentage of region that was stained. The average percent of region that was stained was calculated and reported. | The analysis population consists of all subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes. | Posted | Mean | Standard Deviation | Average Percentage of Staining | Baseline to 4- Week Follow-up | Subject Eyes | Subject Eyes |
|
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| 0 |
| 39 |
| 0 |
| 39 |
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| Grade 2 - 26% to 50% Staining |
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| Grade 3 - 51% to 75% Staining |
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| Grade 4 - 76% to 100% Staining |
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| Inferior |
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| Temporal |
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| Superior |
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