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This is a double-masked, bilateral, randomized, non-dispensing clinical trial. The study lenses will be worn in a bilateral and random fashion using a 5x5 crossover Williams design with 5 lens types and 5 periods. The subjects will wear each pair of lenses for approximately 15 minutes with a 15 minute wash-out between each pair. Two lens types will be fit at the first visit and three lens types will be fit at the second visit. Using a computer-generated randomization scheme, each subject will randomly be assigned to 1 of 10 unique sequences of the 5 lens types. Randomization will be stratified by site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 4 (experimental) |
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| Sequence 2 | Experimental | etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Control Lens (Active Comparator) |
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| Sequence 3 | Experimental | etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 1 (experimental) |
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| Sequence 4 | Experimental | etafilcon A Test Lens 4 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 1 (experimental) |
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| Sequence 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A Investigational Toric Multifocal Contact Lens | Device | Test Lens 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Handling Comparison Between Test 1/Test 2 and Control | Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Handling Comparison Between Test 3/Test 4 and Control | Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden Optometric Group | Whittier | California | 90606 | United States | ||
| Bay Hill Eye Care |
Subjects were randomized to 1 of 10 unique lens sequences.
A total of 96 subjects were enrolled in this study, of which 91 subjects were assigned at least 1 study lens, 5 subjects failed to meet all eligibility criteria. Of the total assigned subjects, 88 completed the study, while 3 were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test 3/Test 2/Test 4/Test 1/Control | Subjects randomized to this sequence received the following treatments in order: Test 3 in period 1, Test 2 in period 2, Test 4 in period 3, Test 1 in period 4, Control in period 5. |
| FG001 | Test 3/Test 4/Test 2/Control/Test 1 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2017 |
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etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 3 (experimental) |
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| Sequence 6 | Experimental | etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 2 (experimental / etafilcon A Test Lens 1 (experimental) |
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| Sequence 7 | Experimental | etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental) |
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| Sequence 8 | Experimental | etafilcon A Test Lens 1 (experimental) / etafilcon A Control Lens (Active Comparator) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 4 (experimental / etafilcon A Test Lens 3 (experimental) |
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| Sequence 9 | Experimental | etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 1 (experimental) / etafilcon A Test Lens 3 (experimental / etafilcon A Control Lens (Active Comparator) /etafilcon A Test Lens 4 (experimental) |
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| Sequence 10 | Experimental | etafilcon A Test Lens 3 (experimental) / etafilcon A Test Lens 2 (experimental) / etafilcon A Test Lens 4 (experimental) / etafilcon A Test Lens 1 (experimental / etafilcon A Control Lens (Active Comparator) |
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| etafilcon A Investigational Toric Multifocal Contact Lens | Device | Test Lens 2 |
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| etafilcon A Investigational Toric Multifocal Contact Lens | Device | Tes Lens 3 |
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| etafilcon A Investigational Toric Multifocal Contact Lens | Device | Test Lens 4 |
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| etafilcon A Investigational Toric Multifocal Contact Lens | Device | Control Lens |
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| 15 minutes |
| Orlando |
| Florida |
| 32819 |
| United States |
| Lee & Leong Doctors of Optometry | Kahului | Hawaii | 96732 | United States |
| Spectrum Eyecare | Jamestown | New York | 14750 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Miamisburg Vision Care | Miamisburg | Ohio | 45342 | United States |
| Optometry Group, PLLC | Memphis | Tennessee | 38111 | United States |
Subjects randomized to this sequence received the following treatments in order: Test 3 in period 1, Test 4 in period 2, Test 2 in period 3, Control in period 4, Test 1 in period 5. |
| FG002 | Test 1/Control/Test 2/Test 4/Test 3 | Subjects randomized to this sequence received the following treatments in order: Test 1 in period 1, Control in period 2, Test 2 in period 3, Test 4 in period 4, Test 3 in period 5. |
| FG003 | Test 1/Test 2/Control/Test 3/Test 4 | Subjects randomized to this sequence received the following treatments in order: Test 1 in period 1, Test 2 in period 2, Control in period 3, Test 3 in period 4, Test 4 in period 5. |
| FG004 | Control/Test 1/Test 4/Test 2/Test 3 | Subjects randomized to this sequence received the following treatments in order: Control in period 1, Test 1 in period 2, Test 4 in period 3, Test 2 in period 4, Test 3 in period 5. |
| FG005 | Control/Test 4/Test 1/Test 3/Test 2 | Subjects randomized to this sequence received the following treatments in order: Control in period 1, Test 4 in period 2, Test 1 in period 3, Test 3 in period 4, Test 2 in period 5. |
| FG006 | Test 2/Test 3/Test 1/Test 4 /Control | Subjects randomized to this sequence received the following treatments in order: Test 2 in period 1, Test 3 in period 2, Test 1 in period 3, Test 4 in period 4, Control in period 5. |
| FG007 | Test 2/Test 1/Test 3/Control/Test 4 | Subjects randomized to this sequence received the following treatments in order: Test 2 in period 1, Test 1 in period 2, Test 3 in period 3, Control in period 4, Test 4 in period 5. |
| FG008 | Test 4/Test 3/Control/Test 2/Test 1 | Subjects randomized to this sequence received the following treatments in order: Test 4 in period 1, Test 3 in period 2, Control in period 3, Test 2 in period 4, Test 1 in period 5. |
| FG009 | Test 4/Control/Test 3/Test 1/Test 2 | Subjects randomized to this sequence received the following treatments in order: Test 4 in period 1, Control in period 2, Test 3 in period 3, Test 1 in period 4, Test 2 in period 5. |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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| Period 3 |
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| Period 4 |
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| Period 5 |
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All subjects who were administered study article and completed all required study visits.
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| ID | Title | Description |
|---|---|---|
| BG000 | Completed Subjects | All subjects who were administered study article and completed all required study visits. |
| 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 | |||||||||||||||||
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Handling Comparison Between Test 1/Test 2 and Control | Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | units on a scale | 15 minutes |
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| Secondary | Overall Handling Comparison Between Test 3/Test 4 and Control | Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | units on a scale | 15 minutes |
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Throughout the duration of the study. Approximately 1 week per subject.
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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 1 | Subjects that wore the Test 1 lens in either the first, second, third, fourth, or fifth period of the study. | 0 | 90 | 0 | 90 | 0 | 90 |
| EG001 | Test 2 | Subjects that wore the Test 2 lens in either the first, second, third, fourth, or fifth period of the study. | 0 | 90 | 0 | 90 | 0 | 90 |
| EG002 | Test 3 | Subjects that wore the Test 3 lens in either the first, second, third, fourth, or fifth period of the study. | 0 | 90 | 0 | 90 | 0 | 90 |
| EG003 | Test 4 | Subjects that wore the Test 4 lens in either the first, second, third, fourth, or fifth period of the study. | 0 | 89 | 0 | 89 | 0 | 89 |
| EG004 | Control | Subjects that wore the Control lens in either the first, second, third, fourth, or fifth period of the study. | 0 | 90 | 0 | 90 | 0 | 90 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Karkkainen SR Principal Research Optometrist | Johnson & Johnson Vision Care, Inc. | 1-800-843-2020 | TKarkkai@its.jnj.com |
| Jul 17, 2020 |
| Prot_SAP_000.pdf |
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| White |
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| Other |
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| Mixed Models Analysis | Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom. | Least Square Mean Difference | 2.1 | Standard Error of the Mean | 3.06 | 2-Sided | 95 | -4.0 | 8.1 | LS Mean difference was calculated as Test 2 - Control. | Non-Inferiority | The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5. |
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