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This will be a 5-visit, randomized, partially single-masked, bilateral wear, dispensing, 2-treatment × 2-period crossover study with spectacle-wear washout and wash-in periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control | Experimental | Eligible subjects will be randomized to the sequence, Test/Control |
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| Control/Test | Experimental | Eligible subjects will be randomized to the sequence, Control/Test |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACUVUE Oasys 1-Day with HydraLuxe Technology for Astigmatism | Device | TEST |
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| Measure | Description | Time Frame |
|---|---|---|
| High Luminance High Contrast Monocular Visual Acuity (LogMAR) | Visual Acuity was collected for each subject eye at distance (4 meter) using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. Lower values of visual acuity indicate better vision. The average logMAR Visual Acuity was reported for each lens type. | 1-Week Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| CLUE Vision Score | CLUE Vision 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 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE vision score for each lens type was reported. |
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Inclusion Criteria:
Potential subjects must satisfy of all the following criteria to be enrolled in the study.
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.
Be between 18 and 39 (inclusive) years of age at the time of screening.
By self-report, habitually wear soft contact lenses (sphere or toric) in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 2 days per week during the past 4 weeks.
Possess a wearable pair of spectacles that provide correction for distance vision.
In both eyes, have magnitude of the cylinder component of their vertex-corrected distance refraction greater than or equal to 0.625 DC and less than 1.625 DC.
In both eyes, have the mean sphere of their vertex-corrected distance refraction minus half of the indicated contact lens label cylinder power be between -0.875 to -4.625 DS (inclusive).
For each eye, have the cylinder axis of their distance refraction between 165° and 15° (i.e., 180±15°, inclusive) or between 75° and 105° (i.e., 90±15°, inclusive).
For both eyes, have the sphere power of their habitual spectacles within ±0.50 Diopters Sphere (DS) (inclusive) of the sphere power of their current subjective refraction.
For both eyes, have the cylinder power of their habitual spectacles within ±0.50 Diopters Cylinder (DC) (inclusive) of the cylinder power of their current subjective refraction.
For both eyes, have the cylinder axis of their habitual spectacles within ±20° (inclusive) of the cylinder axis of their current subjective refraction.
Achieve monocular VA of 20/30 or better with their habitual spectacles in both eyes.
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Vision Care, Inc. Clinical Trial | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eyecenter Optometric | Rocklin | California | 95677 | United States | ||
| Sabal Eye Care |
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 174 subjects were enrolled in this study. Of those enrolled, a total of 161 subjects were assigned to one of two wear sequences; while 13 subjects were screen failure and/or not assigned. Of the total assigned subjects, 151 subjects completed the study while, 10 subjects were discontinued from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test/Control | Subjects that wore the Test lens during Period 1 and the Control lens during Period 2. |
| FG001 | Control/Test | Subjects that wore the Control lens during Period 1 and the Test lens during Period 2. |
| 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 | Nov 11, 2021 |
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| ACUVUE Oasys 1-Day with HydraLuxe Technology | Device | CONTROL |
|
| 1-Week Follow-up |
| High Luminance High Contrast Monocular Visual Acuity (LogMAR) | Visual Acuity was collected for each subject eye at distance (4 meter) using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. Lower values of visual acuity indicate better vision. The average logMAR Visual Acuity was reported for each lens type. Data summaries for the Control lens are reported for the first primary measure outcome. | 1-Week Follow-up |
| Subjective Contact Lens Preference | 1-Week Follow-up |
| Longwood |
| Florida |
| 32779 |
| United States |
| Maitland Vision Center | Maitland | Florida | 32751 | United States |
| Windward Vision Ctr Associates Inc. | Kaneohe | Hawaii | 96744 | United States |
| Indiana University School of Optometry | Bloomington | Indiana | 61701 | United States |
| Advanced Eye Care | Raytown | Missouri | 64133 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| University Hospitals of Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| ProCare Vision Center | Granville | Ohio | 43023 | United States |
| Professional Visioncare Inc. | Westerville | Ohio | 43081 | United States |
| Total Eye Care | Memphis | Tennessee | 38119 | United States |
| Tyler Texas Associates | Tyler | Texas | 75703 | United States |
| Botetourt Eyecare, LLC | Salem | West Virginia | 24153 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Total | Subjects that wore either Test lens or Control during the study. |
| 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 (NIH/OMB) | Count of Participants | 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 | High Luminance High Contrast Monocular Visual Acuity (LogMAR) | Visual Acuity was collected for each subject eye at distance (4 meter) using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. Lower values of visual acuity indicate better vision. The average logMAR Visual Acuity was reported for each lens type. | All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. At least one observation was recorded. | Posted | Mean | Standard Deviation | logMAR | 1-Week Follow-up | eyes | eyes |
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| Secondary | CLUE Vision Score | CLUE Vision 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 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE vision score for each lens type was reported. | All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. At least one observation was recorded. | Posted | Mean | Standard Deviation | units on a scale | 1-Week Follow-up |
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| Secondary | High Luminance High Contrast Monocular Visual Acuity (LogMAR) | Visual Acuity was collected for each subject eye at distance (4 meter) using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. Lower values of visual acuity indicate better vision. The average logMAR Visual Acuity was reported for each lens type. Data summaries for the Control lens are reported for the first primary measure outcome. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | logMAR | 1-Week Follow-up | eyes | eyes |
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| Secondary | Subjective Contact Lens Preference | All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. At least one observation was recorded. | Posted | Number | proportion of participants | 1-Week Follow-up |
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Throughout the duration of the study; The study duration for each subject was approximately 2 weeks.
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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 either period of the study | 0 | 157 | 0 | 157 | 0 | 157 |
| EG001 | Control | Subjects that wore the Control lens during either period of the study. | 0 | 157 | 0 | 157 | 0 | 157 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Straker-Principal Research Optometrist | Johnson & Johnson Vision Care, Inc. | 1-800-843-2020 | bstraker@its.jnj.com |
| Feb 27, 2023 |
| Prot_SAP_000.pdf |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| eyes |
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| Denominators |
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| Categories |
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| Prefer Test |
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| Prefer Control |
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| No Preference |
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