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| Name | Class |
|---|---|
| Visioncare Research Ltd. | OTHER |
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The objective of the study is to compare the clinical performance of silicone hydrogel daily disposable contact lenses, conventional hydrogel daily disposable contact lenses and silicone hydrogel monthly replacement contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| narafilcon B daily disposable 4 weeks | Experimental | narafilcon B soft contact lenses worn daily on a daily disposable/replacement schedule, for 4 weeks |
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| nelfilcon A daily disponsable 1 week | Active Comparator | nelfilcon A soft contact lenses worn daily on a daily disposable/replacement schedule, for 1 week |
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| lotrafilcon B daily wear, monthly replacement, 4-weeks | Active Comparator | lotrafilcon B soft contact lenses worn daily on a 1-month replacement schedule, for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| narafilcon B contact lens | Device | Silicone Hydrogel Daily Disposable Contact Lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort Narafilcon B v. Nelfilcon A | Contact Lens User Experience (CLUE)TM questionnaire: 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. | After 1 week |
| Signs of Limbal Hyperemia Narafilcon B v. Nelfilcon A | Redness scale of 0 to 4, where 0=None, 4=Severe redness | After 1 Week |
| Subjective Rating of Overall Comfort Narafilcon B v. Lotrafilcon B | Contact Lens User Experience (CLUE)TM questionnaire: 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. | After 4 Weeks |
| Signs of Limbal Hyperemia Narafilcon B v. Lotrafilcon B | Redness scale of 0 to 4, where 0=None, and 4=Severe. | After 4 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Signs of Inferior Corneal Staining Narafilcon B v. Nelfilcon A | Standard scale of 0 to 3 where 0=None, 3=Severe staining | After 1 Week |
| Subjective Rating of Overall Ease of Lens Handling Narafilcon B v Nelfilcon A |
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Inclusion Criteria:
Be no less than 18 and no more than 39 years of age.
Sign Written Informed Consent and investigator to record this on Case Report Form (See separate document).
Be willing and able to adhere to the instructions set out in the protocol.
Own a cell phone and be willing to receive text messages during the day.
Be an existing successful daily wear soft contact lens. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month.
No extended wear in the last 3 months.
Subjective refraction must result in a vertexed spherical contact lens prescription between -1.00 and -6.00D.
Have refractive astigmatism less than or equal to 1.00D in both eyes.
Achieve visual acuity of 6/9 (20/30) or better in each eye.
Require a visual correction in both eyes (no monofit or monovision allowed).
Does not require presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
No amblyopia.
No evidence of lid abnormality or infection (including blepharitis/meibomitis).
Exclusion Criteria:
Does not require presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brea | California | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Narafilcon B 4 Weeks | lenses worn daily on a daily disposable/replacement schedule, for 4 weeks |
| FG001 | Nelfilcon A 1 Week | lenses worn daily on a daily disposable/replacement schedule, for 1 week |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| nelfilcon A contact lens | Device | Conventional Hydrogel Daily Disposable Contact Lenses |
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| lotrafilcon B contact lens | Device | Silicone Hydrogel Monthly Replacement Contact Lenses |
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Contact Lens User Experience (CLUE)TM questionnaire: 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.
| After 1 Week |
| Subjective Rating of End of Day Comfort Narafilcon B v. Nelfilcon A | Scale of 1 to 5, where 1=Poor comfort and 5=Excellent comfort | After 1 Week |
| Subjective Rating of Initial Comfort Narafilcon B v. Nelfilcon A | Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort. | After 1 Week |
| Signs of Inferior Corneal Staining Narafilcon B v. Lotrafilcon B | Scale of 0 to 3, where 0=none and 3=severe staining. | After 4 Weeks |
| Subjective Rating of Overall Ease of Lens Handling Narafilcon B v. Lotrafilcon B | Contact Lens User Experience (CLUE)TM questionnaire: 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. | After 4 Weeks |
| Subjective Rating of End of Day Comfort Narafilcon B v. Lotrafilcon B | Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort | After 4 Weeks |
| Subjective Rating of Initial Comfort Narafilcon B v. Lotrafilcon B | Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort, 5=excellent comfort. | After 4 Weeks |
| Canoga Park |
| California |
| United States |
| Corona | California | United States |
| Bridgeport | Connecticut | United States |
| Jacksonville | Florida | 32205 | United States |
| Jacksonville | Florida | 32256 | United States |
| Tampa | Florida | United States |
| Winter Park | Florida | United States |
| Roswell | Georgia | United States |
| Mishawaka | Indiana | United States |
| Boston | Massachusetts | United States |
| Blue Springs | Missouri | United States |
| Independence | Missouri | United States |
| Lake Ozark | Missouri | United States |
| New York | New York | United States |
| Raleigh | North Carolina | United States |
| Chagrin Falls | Ohio | United States |
| North Olmsted | Ohio | United States |
| Warren | Ohio | United States |
| Kittanning | Pennsylvania | United States |
| State College | Pennsylvania | United States |
| Warwick | Rhode Island | United States |
| Bartlett | Tennessee | United States |
| Brentwood | Tennessee | United States |
| Tyler | Texas | 75701 | United States |
| Tyler | Texas | 75703 | United States |
| Burlington | Vermont | United States |
| Virginia Beach | Virginia | United States |
| FG002 | Lotrafilcon B 4 Weeks | lenses worn daily on a 1-month replacement schedule, for 4 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Narafilcon B 4 Weeks | lenses worn daily on a daily disposable/replacement schedule, for 4 weeks |
| BG001 | Nelfilcon A 1 Week | lenses worn daily on a daily disposable/replacement schedule, for 1 week |
| BG002 | Lotrafilcon B 4 Weeks | lenses worn daily on a 1-month replacement schedule, for 4 weeks |
| BG003 | Total | Total of all reporting groups |
| 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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| 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 | Overall Comfort Narafilcon B v. Nelfilcon A | Contact Lens User Experience (CLUE)TM questionnaire: 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. | Posted | Mean | Standard Deviation | units on a scale | After 1 week |
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| Primary | Signs of Limbal Hyperemia Narafilcon B v. Nelfilcon A | Redness scale of 0 to 4, where 0=None, 4=Severe redness | Posted | Mean | Standard Deviation | Units on a scale | After 1 Week | eyes | eyes |
|
| ||||||||||||||||||||||||||||
| Primary | Subjective Rating of Overall Comfort Narafilcon B v. Lotrafilcon B | Contact Lens User Experience (CLUE)TM questionnaire: 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. | Posted | Mean | Standard Deviation | units on a scale | After 4 Weeks |
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| Secondary | Signs of Inferior Corneal Staining Narafilcon B v. Nelfilcon A | Standard scale of 0 to 3 where 0=None, 3=Severe staining | Posted | Mean | Standard Deviation | units on a scale | After 1 Week | eyes | eyes |
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| Secondary | Subjective Rating of Overall Ease of Lens Handling Narafilcon B v Nelfilcon A | Contact Lens User Experience (CLUE)TM questionnaire: 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. | Posted | Mean | Standard Deviation | units on a scale | After 1 Week |
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| Secondary | Subjective Rating of End of Day Comfort Narafilcon B v. Nelfilcon A | Scale of 1 to 5, where 1=Poor comfort and 5=Excellent comfort | Posted | Mean | Standard Error | units on a scale | After 1 Week |
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| Secondary | Subjective Rating of Initial Comfort Narafilcon B v. Nelfilcon A | Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort. | Posted | Mean | Standard Error | units on a scale | After 1 Week |
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| Secondary | Signs of Inferior Corneal Staining Narafilcon B v. Lotrafilcon B | Scale of 0 to 3, where 0=none and 3=severe staining. | Posted | Mean | Standard Deviation | units on a scale | After 4 Weeks |
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| Secondary | Subjective Rating of Overall Ease of Lens Handling Narafilcon B v. Lotrafilcon B | Contact Lens User Experience (CLUE)TM questionnaire: 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. | Posted | Mean | Standard Deviation | units on a scale | After 4 Weeks |
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| Secondary | Subjective Rating of End of Day Comfort Narafilcon B v. Lotrafilcon B | Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort | Posted | Mean | Standard Error | units on a scale | After 4 Weeks |
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| Secondary | Subjective Rating of Initial Comfort Narafilcon B v. Lotrafilcon B | Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort, 5=excellent comfort. | Posted | Mean | Standard Error | units on a scale | After 4 Weeks |
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| Primary | Signs of Limbal Hyperemia Narafilcon B v. Lotrafilcon B | Redness scale of 0 to 4, where 0=None, and 4=Severe. | Posted | Mean | Standard Deviation | units on a scale | After 4 Weeks | eyes | eyes |
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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 | Narafilcon B 4 Weeks | lenses worn daily on a daily disposable/replacement schedule, for 4 weeks | 0 | 149 | 0 | 149 | ||
| EG001 | Nelfilcon A 1 Week | lenses worn daily on a daily disposable/replacement schedule, for 1 week | 0 | 150 | 0 | 150 | ||
| EG002 | Lotrafilcon B 4 Weeks | lenses worn daily on a 1-month replacement schedule, for 4 weeks | 0 | 153 | 0 | 153 |
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The sponsor must provide written approval for any publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathy Lorenz-Osborn, OD | Vistakon | +1 904 443-1032 | kosborn@its.jnj.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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