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The purpose of this study is to determine the relative performance of a new daily disposable toric soft contact lens against a daily disposable toric contact lens currently available in market, specifically with regards to the comfort and vision with the lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etafilcon A toric contact lens/Nelfilcon A toric | Other | Etafilcon A toric contact lens first, then nelfilcon A toric second |
|
| Nelfilcon A toric/ Etafilcon A toric | Other | Nelfilcon A toric contact lens first, then etafilcon A toric toric second |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etafilcon A toric contact lens | Device | contact lens to correct astigmatism |
|
| Measure | Description | Time Frame |
|---|---|---|
| Monocular Visual Acuity on LogMAR Scale | Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line. | After 5 to 9 days of lens wear |
| Binocular Visual Acuity on LogMAR Scale | Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice binocularly. Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line. | After 5 to 9 days of lens wear |
| Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire | The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90049 | United States | |||
One subject failed screening, and did not enter group assignment
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A Toric Lens First/ Nelfilcon A Toric Lens Second | Etafilcon A toric contact lens worn daily during first period of 5 - 9 days, then nelfilcon A toric contact lens worn daily during second period of 5 - 9 days |
| FG001 | Nelfilcon A Toric Lens First/Etafilcon A Toric Lens Second | Nelfilcon A toric contact lens worn daily during first period of 5 - 9 days, then etafilcon A toric contact lens worn daily during second period of 5 - 9 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (5-9 Days) |
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| ||||||||||||||||||
| Period 2 (5-9 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects who completed the study. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Monocular Visual Acuity on LogMAR Scale | Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line. | Analysis was conducted on subjects who successfully complete the study. | Posted | Mean | Standard Deviation | logMAR | After 5 to 9 days of lens wear |
|
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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 Toric / Nelfilcon A Toric | etafilcon A toric contact lens worn daily during first period of a maximum of 9 days, nelfilcon A toric contact lens worn during second period of a maximum of 9 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ross Franklin | Johnson & Johnson Vision Care | 1-904-443-1379 | RFrankl1@its.jnj.com |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Nelfilcon A toric contact lens | Device | contact lens to correct astigmatism |
|
| After 5 to 9 days of lens wear |
| Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire. | The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD). | After 5 to 9 days of lens wear |
| Jacksonville |
| Florida |
| 32205 |
| United States |
| Jacksonville | Florida | 32256 | United States |
| Marietta | Georgia | 30060 | United States |
| New York | New York | 10001 | United States |
| Warwick | Rhode Island | 02886 | United States |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Etafilcon A Toric (Test Lens) |
Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days |
| OG001 | Nelfilcon A Toric (Active Comparator) | An existing, daily disposable toric contact lens; worn 5-9 days |
|
|
|
| Primary | Binocular Visual Acuity on LogMAR Scale | Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice binocularly. Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line. | Analysis was conducted on subjects who successfully complete the study. | Posted | Mean | Standard Deviation | LogMAR | After 5 to 9 days of lens wear |
|
|
|
|
| Primary | Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire | The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD). | Analysis was conducted on subjects who successfully complete the study. | Posted | Mean | Standard Deviation | units on a scale | After 5 to 9 days of lens wear |
|
|
|
|
| Primary | Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire. | The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD). | Analysis was conducted on subjects who successfully complete the study. | Posted | Mean | Standard Deviation | units on a scale | After 5 to 9 days of lens wear |
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| 0 |
| 69 |
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| 69 |
Publications require agreement and written approval from Sponsor.
| Non-Inferiority or Equivalence |
Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error. |
| Non-Inferiority or Equivalence |
Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error. |
| Non-Inferiority or Equivalence |
Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error. |