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Subjects will evaluate each study lens in a random order. The lenses will be worn in both eyes for a short period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A(sphere)/etafilcon A(multi-focal) | Active Comparator | Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (sphere) contact lens first and then the etafilcon A (multi-focal) contact lens second. |
|
| etafilcon A(multi-focal)/etafilcon A(sphere) | Active Comparator | Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (multi-focal) contact lens first and then the etafilcon A (sphere) contact lens second. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A (multi-focal) | Device | Each subject will wear the soft contact lenses for 15 minutes then remove the lenses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire. | CLUE Overall Lens Handling is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). | 15 minutes post Contact Lens Insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baymeadows Vision Center | Jacksonville | Florida | 32256 | United States | ||
| Eye Elements Eyecare |
This study enrolled a total of 195 subjects. Of those enrolled, 4 subjects did not meet the eligibility criteria, and 191 subjects were dispensed study lenses. Of those dispensed, subjects 189 completed the study and 2 subjects were discontinued. Subjects were stratified as either Hyperops or Myopes based on their sphere power.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A(Multi-focal)/Etafilcon A(Sphere) | Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A (sphere) contact lens and then received the etafilcon A (multi-focal) contact lens. |
| FG001 | Etafilcon A(Sphere)/Etafilcon A(Multi-focal) | Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A (sphere) contact lens and then received the etafilcon A(multi-focal) contact lens. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (15 Minutes) |
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| Period 2 (15 Minutes) |
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The analysis population consists of subjects that were dispensed at least one study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etafilcon A(Multi-focal)/ Etafilcon A(Sphere) | Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A(multi-focal) contact lens and then received the etafilcon A(sphere) contact lens. |
| BG001 | Etafilcon A(Sphere) / Etafilcon A(Multi-focal) |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire. | CLUE Overall Lens Handling is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). | The analysis population consist of subjects that completed all study visits without a major protocol deviation. The analysis was conducted for each lens and strata. | Posted | Mean | Standard Deviation | units on a scale | 15 minutes post Contact Lens Insertion |
|
Throughout the duration of the study (approximately 1 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 | Etafilcon A (Multi-focal) | Subjects that received the etafilcon A (multi-focal) contact lens during either the first or second period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas R. Karkkainen, O.D., M.S., F.A.A.O., Sr. Principal Research 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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|
| etafilcon A (sphere) | Device | Each subject will wear the soft contact lenses for 15 minutes then remove the lenses. |
|
|
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Vistakon Research Clinic | Jacksonville | Florida | 32256 | United States |
| Golden Family Eyecare | Sarasota | Florida | 34232 | United States |
| Eye Associates of Winter Park | Winter Park | Florida | 32792 | United States |
| Central Ohio Eyecare | Columbus | Ohio | 43202 | United States |
| Optometry Group LLC | Memphis | Tennessee | 38111 | United States |
| Nashville Vision Associates | Nashville | Tennessee | 37205 | United States |
| Myopes |
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| COMPLETED |
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| NOT COMPLETED |
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Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A(sphere) contact lens and then received the etafilcon A(multi-focal) contact lens. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| 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 |
|
Subjects that received the etafilcon A (multi-focal) contact lens during either the first or second period of the study.
| OG001 | Etafilcon A (Sphere) | Subjects that received the etafilcon A (sphere) contact lens during either the first or second period of the study. |
|
|
| 0 |
| 191 |
| 0 |
| 191 |
| EG001 | Etafilcon A (Sphere) | Subjects that received the etafilcon A (sphere) contact lens during either the first or second period of the study. | 0 | 191 | 0 | 191 |
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