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This study is a multi-site, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear both Test and Control lenses in each eye 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 |
|---|---|---|---|
| Test/Control | Experimental | Eligible subjects that are habitual wearers of hydrogel daily disposable contact lenses in both eyes will be randomly assigned to one of two sequences, (Test/Control) or (Control/Test). |
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| Control/Test | Experimental | Eligible subjects that are habitual wearers of hydrogel daily disposable contact lenses in both eyes will be randomly assigned to one of two sequences, (Test/Control) or (Control/Test). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1-DAY ACUVUE® MOIST | Device | etafilcon A contact lenses made with a new manufacturing technology |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort Score | Overall comfort score 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 (standard deviation [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 | Overall quality of vision 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. 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 |
| Measure | Description | Time Frame |
|---|---|---|
| LogMAR Visual Performance Scale | Visual acuity measured via Early Treatment Diabetic Retinopathy Study (ETDRS) charts (logMAR) can take on any possible value. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance is reported for each lens type on high contrast dim light and low contrast bright light. | 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:
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.
The subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lenses in both eyes (at least 1 month of daily wear).
The subject must have normal eyes (i.e., no ocular medications or infections of any type).
The subject's required spherical contact lens prescription must be in the range of -0.50 to -6.00 D in each eye.
The subject's refractive cylinder must be < 0.75D in each eye.
The subject must have best corrected visual acuity of 20/25 or better in each eye.
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maitland Vision Center | Maitland | Florida | 32751 | United States | ||
| Eyecare Associates, LLP |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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A total of 95 participants were enrolled in this study however one participant was never randomized due to screen failure therefore, 94 participants were randomized to receive study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test/Control | Subjects randomized to this sequence received the Test lens during the first period and then received the control lens during the second period. |
| FG001 | Control/Test | Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Set | All subjects dispensed a 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 Score | Overall comfort score 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 (standard deviation [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. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | Units on a scale | 1-Week Follow-up |
|
Throughout the duration of the study. Approximately 3-4 Weeks per participant
All participants dispensed at least 1 study lens.
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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 Test for Novel | Subjects who wore the Test lens made with a novel manufacturing technology in either the first or second period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Pall, Director Clinical Science, Vision Care | Johnson & Johnson Vision Care | 1-800-843-2020 | 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 | Apr 26, 2019 | Jul 8, 2020 | Prot_SAP_000.pdf |
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| 1-DAY ACUVUE® MOIST | Device | etafilcon A contact lenses made with the current manufacturing technology |
|
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| Average Daily Wear Time | Average daily wear time was calculated as the number of hours between participants reported time of insertion and time of removal of the study lenses, on an average day, at 1-Week follow-up evaluation. | 1-Week follow-up |
| Bloomington |
| Illinois |
| 61701 |
| United States |
| Manhattan Vision Associates | New York | New York | 10022 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Eyecare Professionals of Powell | Powell | Ohio | 43065 | United States |
| Frazier Vision | Tyler | Texas | 75703 | United States |
| No Longer Meets Eligibility Criteria |
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| Withdrawal by Subject |
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| NOT COMPLETED |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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Subjects who wore the Test lens made with a novel manufacturing technology in either the first or second period of the study. |
| OG001 | Etafilcon A Control for Current | Subjects that wore the Control lens made with the current manufacturing technology in either the first or second period of the study. |
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| Primary | Overall Vision Score | Overall quality of vision 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. 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. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | Units on a scale | 1-Week Follow-up |
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| Secondary | LogMAR Visual Performance Scale | Visual acuity measured via Early Treatment Diabetic Retinopathy Study (ETDRS) charts (logMAR) can take on any possible value. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance is reported for each lens type on high contrast dim light and low contrast bright light. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | logMAR units | 1-Week follow-up | Eyes | Eyes |
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| Secondary | Average Daily Wear Time | Average daily wear time was calculated as the number of hours between participants reported time of insertion and time of removal of the study lenses, on an average day, at 1-Week follow-up evaluation. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | Hours | 1-Week follow-up |
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| 0 |
| 92 |
| 0 |
| 93 |
| 0 |
| 93 |
| EG001 | Etafilcon A Control for Current | Subjects that wore the Control lens made with the current manufacturing technology in either the first or second period of the study. | 0 | 91 | 0 | 90 | 0 | 90 |
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| Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses. | Posterior Mean Difference | -0.002 | Standard Deviation | 0.0057 | 2-Sided | 95 | -0.014 | 0.009 | Posterior mean difference was calculated as Test - Control | Non-Inferiority | Non-inferiority was declared if the upper bound of the CrI of the mean difference between Test and Control was less than 0.05. |