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This is a bilateral, dispensing, randomized, controlled, double-masked, 2×2 cross-over study to evaluate the clinical performance of ACUVUE OASYS® 1-Day for Astigmatism contact lenses produced on a recently qualified manufacturing line.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEST/CONTROL | Experimental | Eligible subjects that are habitual contact lens wearers will be randomized into the (TEST/CONTROL) sequence and will wear two different study lenses one at a time over the two wear periods. During each wear period the lenses will be worn bilaterally for approximately 1 week. Study lenses will be worn for a minimum of 8 hours per day and at least 5 days per week during the wear period. |
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| CONTROL/TEST | Experimental | Eligible subjects that are habitual contact lens wearers will be randomized into the (CONTROL/TEST) sequence and will wear two different study lenses one at a time over the two wear periods. During each wear period the lenses will be worn bilaterally for approximately 1 week. Study lenses will be worn for a minimum of 8 hours per day and at least 5 days per week during the wear period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACUVUE OASYS® 1-Day for Astigmatism - TAM 24 | Device | TEST |
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| Measure | Description | Time Frame |
|---|---|---|
| CLUE Comfort Score | Overall 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. | Fitting, 1-Week Follow-up |
| CLUE Vision Score | Overall 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 with a range of 0-120. | Fitting, 1-Week Follow-up |
| CLUE Handling Score | 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. | Fitting, 1-Week Follow-up |
| Monocular Visual Performance (LogMAR) | Visual performance was calculated as monocular contact lens-corrected distance visual acuity 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. Lower visual performance values indicate better vision. Two measurements were performed for each eye. The average visual performance was reported for each lens type. |
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Inclusion Criteria:
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject must:
Exclusion Criteria:
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
The subject must not:
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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 |
|---|---|---|---|---|---|---|
| Sabal Eye Care | Longwood | Florida | 32779 | United States | ||
| VisionPoint Eye Center |
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 72 subjects were enrolled in this study. Of those enrolled, a total of 71 subjects were assigned to one of two wear sequences; while one subject was a screen failure and/or not assigned. Of the total assigned subjects, 68 subjects completed the study while, 3 subjects were discontinued from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control/Test | Subjects that wore the Control lens in a bilateral fashion during Period 1 and the Test lens during Period 2. |
| FG001 | Test/Control | Subjects that wore the Test lens in a bilateral fashion during Period 1 and the Control 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 5, 2020 |
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| ACUVUE OASYS® 1-Day for Astigmatism |
| Device |
CONTROL |
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| 1-Week Follow-up |
| Lens Rotation | Lens rotation was recorded from direction and magnitude in degrees to the nearest degree at one and three minutes following lens insertion during settling period. All lenses in this study have scribe marks at 6 o'clock and 12 o'clock positions and rotation measurements were made relative to a vertical reference line. | Post-Fitting at 1-minute, at 3-minute |
| Settled Rotation | Mean settled rotation was calculated from all repeated measures of signed lens orientation upon settling for each subject/eye/lens. | Fitting, 1-Week Follow-up |
| Bloomington |
| Illinois |
| 61704 |
| United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Professional Vision Care, Inc. | Westerville | Ohio | 43081 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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All subjects dispensed a study article.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subject | All subjects dispensed a study article. |
| 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/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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CLUE Comfort Score | Overall 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 | Fitting, 1-Week Follow-up |
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| Primary | CLUE Vision Score | Overall 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 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 | Fitting, 1-Week Follow-up |
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| Primary | CLUE Handling Score | 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. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a scale | Fitting, 1-Week Follow-up |
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| Primary | Monocular Visual Performance (LogMAR) | Visual performance was calculated as monocular contact lens-corrected distance visual acuity 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. Lower visual performance values indicate better vision. Two measurements were performed for each eye. The average visual performance was reported for each lens type. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | LogMAR | 1-Week Follow-up | eye | eye |
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| Primary | Lens Rotation | Lens rotation was recorded from direction and magnitude in degrees to the nearest degree at one and three minutes following lens insertion during settling period. All lenses in this study have scribe marks at 6 o'clock and 12 o'clock positions and rotation measurements were made relative to a vertical reference line. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Degrees | Post-Fitting at 1-minute, at 3-minute | eye | eye |
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| Primary | Settled Rotation | Mean settled rotation was calculated from all repeated measures of signed lens orientation upon settling for each subject/eye/lens. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Degrees | Fitting, 1-Week Follow-up | eye | eye |
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Throughout the duration of the study; approximately 3 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 | Test | All subjects that wore the Test lens during any of the 2 wear periods. | 0 | 71 | 0 | 71 | 0 | 71 |
| EG001 | Control | All subjects that wore the Control lens during any of the 2 wear periods. | 0 | 71 | 0 | 71 | 0 | 71 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Straker - Principal Research Optometrist | Johnson & Johnson VIsion Care, Inc. | 1-904-312-0604 | bstraker@its.jnj.com |
| Mar 28, 2022 |
| Prot_SAP_000.pdf |
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