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This is a single-site, 8-visit, double-masked, cross-over study involving three marketed products as study lenses. Participants will be randomly assigned each lens type, which will be worn for approximately two weeks (12 +/- 2 days) each. Participants will undergo a minimum washout period of 3 days before entering the study and undergo a minimum 7 day washout period between dispensing each lens type.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens 1/ Lens 2/ Lens 3 | Active Comparator | Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 1 (etafilcon A), then wear Lens 2 (nelfilcon A) second and then wear Lens 3 (nesofilcon A) third. |
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| Lens 1 / Lens 3 / Lens 2 | Active Comparator | Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 1 (etafilcon A), then wear Lens 3 (nesofilcon A) second and then wear Lens 2 (nelfilcon A) third. |
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| Lens 2/ Lens 3/ Lens 1 | Active Comparator | Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 2 (nelfilcon A), then wear Lens 3 (nesofilcon A) second and then wear Lens 1 (etafilcon A) third . |
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| Lens 2 / Lens 1/ Lens 3 | Active Comparator | Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 2 (nelfilcon A), then wear Lens 1 (etafilcon A) second and then wear Lens 3 (nesofilcon A) third. Each lens type will be worn for approximately 2 weeks (12 +/- 2 days). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens 1 (etafilcon A) | Device | Each lens type will be worn for approximately 2 weeks (12 +/- 2 days). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort | Clue comfort 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. | 2- Week Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Contact Lens Research | Waterloo | Ontario | N2L 3G1 | Canada |
A total of 78 subjects were enrolled in this study. Of the enrolled subjects 74 subjects were dispensed at least 1 study lens and 4 subjects did not meet the eligbility criteria. Of the dispensed subjects 72 completed the study and 2 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A/ Nelfilcon A/ Nesofilcon A | All subjects that were randomized to receive the etafilcon A lens first, the nelfilcon A lens second and the nesofilcon A lens third. |
| FG001 | Etafilcon A/ Nesofilcon A/ Nelfilcon A | All subjects that were randomized to receive the etafilcon A lens first, the nesofilcon A lens second and the nelfilcon A lens third. |
| FG002 | Nelfilcon A/ Nesofilcon A/ Etafilcon A | All subjects that were randomized to receive the nelfilcon A lens first, the nesofilcon A lens second and the etafilcon A lens third. |
| FG003 | Nelfilcon A/ Etafilcon A/ Nesofilcon A | All subjects that were randomzied to receive the nelfilcon A lens first, the etafilcon A lens second and the nesofilcon A lens third. |
| FG004 | Nesolfilcon A/ Etafilcon A/ Nelfilcon A | All subjects that were randomized to receive the nesofilcon A lens first, the etafilcon A lens second and the nelfilcon A lens third. |
| FG005 | Nesofilcon A/ Nelfilcon A/Etafilcon A | All subjects that were randomized to receive the nesofilcon A lens first, the nelfilcon A lens second and the etafilcon A lens third. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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All subjects that were dispensed at least 1 study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects that were dispensed at least 1 study lens. |
| 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 | Overall Comfort | Clue comfort 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. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a scale | 2- Week Follow-up |
|
Throughout the entire duration of the study. Approximately 6 weeks 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 | Etafilcon A | All subjects that wore the etafilcon A lens during any one of the 3 periods in the study. |
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Caution of interpretation of results: A significant first-order carryover effect was noted in the study analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chantal Coles-Brennan BSc, OD, FAAOPrincipal Research Optometrist | Johnson & Johnson Vision Care Inc. | 904 443 3449 | CColesb@ITS.JNJ.com |
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| Lens 3 / Lens 1 / Lens 2 | Active Comparator | Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 3 (nesofilcon A), then wear Lens 1 (etafilcon A) second and then wear Lens 3 (nelfilcon A) third. |
|
| Lens 3 / Lens 2 / Lens 1 | Active Comparator | Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 3 (nesofilcon A), then wear Lens 2 (nelfilcon A) second and then wear Lens 3 (etafilcon A) third. |
|
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| Lens 2 (nelfilcon A) | Device | Each lens type will be worn for approximately 2 weeks (12 +/- 2 days). |
|
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| Lens 3 (nesofilcon A) | Device | Each lens type will be worn for approximately 2 weeks (12 +/- 2 days). |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| 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 |
|
| OG001 |
| Nelfilcon A |
All subjects that wore the nelfilcon A lens in any of the 3 periods of the study. |
| OG002 | Nesofilcon A | All subjects that wore the nesofilcon A lens in any of the 3 periods in the study. |
|
|
| 0 |
| 74 |
| 0 |
| 74 |
| EG001 | Nelfilcon A | All subjects that wore the nelfilcon A lens in any of the 3 periods of the study. | 0 | 74 | 0 | 74 |
| EG002 | Nesofilcon A | All subjects that wore the nesofilcon A lens in any of the 3 periods in the study. | 0 | 74 | 0 | 74 |
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