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The objective of this study is to evaluate the performance of a novel multifocal lens system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A/lotrafilcon B | Active Comparator | Subjects were randomized to one of two lens wear sequences. Subject randomized to this sequence first wore the etafilcon A lens and then wore the lotrafilcon B lens. |
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| lotrafilcon B/etafilcon A | Active Comparator | Subjects were randomized to one of two lens wear sequences. Subject randomized to this sequence first wore the lotrafilcon B lens and then wore the etafilcon A lens. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device | To be worn in a daily wear modality for a minimum of 6 hours per day. |
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| Measure | Description | Time Frame |
|---|---|---|
| Binocular Distance Visual Acuity (LogMAR) | Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast, at 4m under 250 cd/m^2. The test was presented under the condition High luminance (250 cd/m^2) High Contrast (90%) | 8-12 days post wear |
| Binocular Near Visual Acuity (logMAR) | Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast, at 40cm under 250 cd/m^2. The test was presented under the condition High Luminance (250cd/m^2) High Contrast (90%). | 8-12 days post wear |
| Percentage of Eyes With Corneal Staining Grade 3 or Higher | Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher and those subjects with less than Grade 3 for the maximum grade of corneal staining across all 5 regions. | 8-12 days post wear |
| Percentage of Eyes With Limbal Conjunctival Redness Grade 3 or Higher | The Limbus refers to the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjuctival Redness was graded in 4 regions (Nasal, Temporal, Inferior and Superior) using the Efron Grading Scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4: Severe. The data was dichotomized into two group subjects with grade 3 or higher Limbal Conjuctival Redness, and those subjects with less than Grade 3 for the maximum grade of all 4 regions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mission Viejo | California | United States | ||||
| RPS |
This study enrolled a total of 298 subjects. Subjects were stratified as either Hyperopes or Myopes, which was determined by their sphere power. Of the enrolled subjects 22 did not meet the eligibility criteria and 276 subjects were randomized a study lens. Of the randomized subjects 29 were discontinued and 247 subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A/ Lotrafilcon B | Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the etafilcon A lens and then received the lotrafilcon B lens. |
| FG001 | Lotrafilcon B/ Etafilcon A |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| lotrafilcon B | Device | Lenses will be worn in a reuseable modality; cleaned and disinfected each night. |
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| 8-12 days post wear |
| Percentage of Eyes With Bulbar Conjunctival Redness Grade 3 or Higher | Bulbar Conjunctival Injection was assessed in 4 regions (Nasal, Temporal, Inferior and Superior) using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3 for the maximum grade of all 4 regions. | 8-12 days post wear |
| CLUE Overall Quality of Vision Using the Contact Lens User Experience (CLUE)TM Questionnaire | CLUE Overall Quality of Vision 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). | 8-12 days post wear |
| Jacksonville |
| Florida |
| United States |
| Jacksonville | Florida | United States |
| Saint Augustine | Florida | United States |
| Tallahassee | Florida | United States |
| Winter Park | Florida | United States |
| Roswell | Georgia | United States |
| Lutherville | Maryland | United States |
| Closter | New Jersey | United States |
| New York | New York | United States |
| Denver | North Carolina | United States |
| Athens | Ohio | United States |
| Kingston | Pennsylvania | United States |
| Warwick | Rhode Island | United States |
| Memphis | Tennessee | United States |
| Amarillo | Texas | United States |
| Tyler | Texas | United States |
| Salt Lake City | Utah | United States |
| Salem | Virginia | United States |
Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the lotrafilcon B lens and then received the etafilcon A lens.
| Myopes |
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| Hyperopes |
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| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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All randomized subjects that were dispensed at least one study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etafilcon A/ Lotrafilcon B | Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the etafilcon A and then received the lotrafilcon B. |
| BG001 | Lotrafilcon B/ Etafilcon A | Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the lotrafilcon B and then received the etafilcon A. |
| BG002 | Total | Total of all reporting groups |
| 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 | Standard Deviation | 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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| 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 | Binocular Distance Visual Acuity (LogMAR) | Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast, at 4m under 250 cd/m^2. The test was presented under the condition High luminance (250 cd/m^2) High Contrast (90%) | The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on each lens and strata. | Posted | Mean | Standard Deviation | LogMAR | 8-12 days post wear |
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| Primary | Binocular Near Visual Acuity (logMAR) | Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast, at 40cm under 250 cd/m^2. The test was presented under the condition High Luminance (250cd/m^2) High Contrast (90%). | The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on each lens and strata. | Posted | Mean | Standard Deviation | LogMAR | 8-12 days post wear |
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| Primary | Percentage of Eyes With Corneal Staining Grade 3 or Higher | Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher and those subjects with less than Grade 3 for the maximum grade of corneal staining across all 5 regions. | The analysis population consists of subjects that completed all study visits without a major protocol deviation.The analysis was conducted on subject eyes for each lens and strata. | Posted | Number | Percentage of Subject Eyes | 8-12 days post wear | Subject Eyes | Subject Eyes |
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| Primary | Percentage of Eyes With Limbal Conjunctival Redness Grade 3 or Higher | The Limbus refers to the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjuctival Redness was graded in 4 regions (Nasal, Temporal, Inferior and Superior) using the Efron Grading Scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4: Severe. The data was dichotomized into two group subjects with grade 3 or higher Limbal Conjuctival Redness, and those subjects with less than Grade 3 for the maximum grade of all 4 regions. | The Analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes for each lens and strata. | Posted | Number | Percentage of Subject Eyes | 8-12 days post wear | Subject Eyes | Subject Eyes |
|
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| Primary | Percentage of Eyes With Bulbar Conjunctival Redness Grade 3 or Higher | Bulbar Conjunctival Injection was assessed in 4 regions (Nasal, Temporal, Inferior and Superior) using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3 for the maximum grade of all 4 regions. | The Analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes for each lens and strata. | Posted | Number | Percentage of Subject Eyes | 8-12 days post wear | Subject Eyes | Subject Eyes |
|
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| Primary | CLUE Overall Quality of Vision Using the Contact Lens User Experience (CLUE)TM Questionnaire | CLUE Overall Quality of Vision 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 consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on each lens and strata. | Posted | Mean | Standard Deviation | units on a scale | 8-12 days post wear |
|
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Throughout the duration of the study- approximately 3 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 | Test (Etafilcon A) | Subjects that were dispensed the Test lens (etafilcon A) during either the first or second period of the study. | 0 | 276 | 0 | 276 | ||
| EG001 | Control (Lotrafilcon B) | Subjects that were dispensed the Control lens (lotrafilcon B) during either the first or second period of the study. | 0 | 276 | 0 | 276 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas R. Karkkainen, OD., M.S., F.A.A.O- Senior Principal Research Optometrist | Johnson & Johnson Vision Care Inc. | 904-443-3500 | 3402 | TKarkkai@its.jnj.com |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Study Site office Closed |
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| Unsatisfactory Visual Response |
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| Protocol Violation |
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| Unsatisfactory lens Fitting |
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| Male |
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| Asian |
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| Black or African American |
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| Native Hawaiian or other Pacific Islander |
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| White |
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| other |
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| Participants |
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| Subject Eyes |
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| Subject Eyes |
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| Participants |
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