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This study was terminated due to the released lenses not representing what will be made commercially available and thus the objectives could not be met
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This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTROL- etafilcon A current molding | Active Comparator | 1-Day ACUVUE® MOIST |
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| TEST- etafilcon A novel molding | Experimental | Investigational Contact Lens |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test/Control | Device | Subjects that are between the ages of 18-70 years old and habitual wearers of hydrogel daily disposable contact lenses will be randomly assigned to Test/Control sequence with a 7 to 9-day washout period in between treatments |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort Scores | Subjective assessment of comfort will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers. | 1-Week Follow-up |
| Overall Vision Score | Subjective assessment of vision will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers. | 1-Week Follow-up |
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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 |
|---|---|---|---|---|---|---|
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
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On July 06, 2018 Johnson & Johnson Vision terminated this study prematurely after lens testing revealed that the lens thickness in the mid-periphery of the lens were thinner than the lens design targets. As of this date only 3 subjects were enrolled at 1 site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test/Control | Subjects that were radnomized to wear the Test lens during the period and the Control lens during the second period. Both study lens was was to be worn bilaterally for a period of 1-week each. |
| FG001 | Control/Test | Subjects that were radnomized to wear the Control lens during the period and the Test lens during the second period. Both study lens was was to be worn bilaterally for a period of 1-week each. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Subjects | All subjects enrolled into th study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Scores | Subjective assessment of comfort will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers. | Study terminated early. No data was analyzed. | Posted | 1-Week Follow-up |
|
Throughout the entire duration of the study. Approxmiately 3 days 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 | Subjects that wore the Test lens during any time throughout the duration of the study. |
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This study was terminated after additional lens metrology testing revealed that the lens thickness of the contact lenses were thinner than the lens design targets. This reduction in thickness may have altered the handling of the contact lenses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Pall OD, MS, FAAO - Director of Clinical Sciences | Johnson & Johnson Vision Care Inc. | 9044431290 | BPALL@its.jnj.com |
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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 30, 2018 | Jul 3, 2019 | Prot_SAP_000.pdf |
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| Control/Test | Device | Subjects that are between the ages of 18-70 years old and habitual wearers of hydrogel daily disposable contact lenses will be randomly assigned to Control/Test sequence with a 7 to 9-day washout period in between treatments |
|
| NOT COMPLETED |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| OG001 | Control | All subject that were randomized to the Control lens during either period of the study. |
|
| Primary | Overall Vision Score | Subjective assessment of vision will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers. | Study terminated early. No data was analyzed. | Posted | 1-Week Follow-up |
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| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Control | Subjects that wore the Control lens during any time throughout the duration of the study. | 0 | 1 | 0 | 1 | 0 | 1 |
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