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The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| galyfilcon A prototype lens / lotrafilcon B lens | Other | The galyfilcon A prototype lenses will be worn during the first period and lotrafilcon B lenses will be worn during the second period. Each period consists of daily lens wear for one week. |
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| lotrafilcon B lens / galyfilcon A prototype lens | Other | The lotrafilcon B lenses will be worn during the first period and galyfilcon A prototype lenses will be worn during the second period. Each period consists of daily lens wear for one week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| galyfilcon A prototype lens | Device | Silicone hydrogel contact lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity Monocular | Snellen monocular visual acuity measurement | after 1 week of lens wear |
| Visual Acuity Binocular | Snellen binocular visual acuity measurement | after 1 week of lens wear |
| Subjective Assessment of Lens Comfort | 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 of lens wear |
| Subjective Assessment of Quality of Vision | 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 of lens wear |
| Measure | Description | Time Frame |
|---|---|---|
| Limbal Redness | Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe. | after 1 week of lens wear |
| Bulbar Redness | Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacksonville | Florida | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Galyfilcon A Prototype Lens / Lotrafilcon B Lens | All enrolled subjects were to wear both lenses through the course of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Galyfilcon A Prototype Lens / Lotrafilcon B Lens | All enrolled subjects were to wear both lenses through the course of 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 |
| 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 | Visual Acuity Monocular | Snellen monocular visual acuity measurement | All completed subjects | Posted | Number | eyes | after 1 week of lens wear | 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 | Galyfilcon A Prototype Lens / Lotrafilcon B Lens | All enrolled subjects were to wear both lenses through the course of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Huan Sheng, MD, PhD | Johnson & Johnson Vision Care | 1-904-443-3440 | HSheng2@its.jnj.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| lotrafilcon B lens | Device | Silicon Hydrogel contact lens |
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| after 1 week of lens wear |
| Subjective Assessment of Lens Comfort | 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. | 10 minutes after lens insertion at time of initial lens fitting |
| Salem |
| Virginia |
| United States |
| 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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| Units | Counts |
|---|
| Participants |
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| eyes |
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| Primary | Visual Acuity Binocular | Snellen binocular visual acuity measurement | All completed subjects | Posted | Number | participants | after 1 week of lens wear |
|
|
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| Primary | Subjective Assessment of Lens Comfort | 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. | Completed subjects | Posted | Mean | Standard Deviation | units on a scale | after 1 week of lens wear |
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| Secondary | Limbal Redness | Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe. | Posted | Number | eyes | after 1 week of lens wear | eyes | eyes |
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| Secondary | Bulbar Redness | Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe. | Posted | Number | eyes | after 1 week of lens wear | eyes | eyes |
|
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|
| Primary | Subjective Assessment of Quality of Vision | 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 of lens wear |
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| Secondary | Subjective Assessment of Lens Comfort | 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 | 10 minutes after lens insertion at time of initial lens fitting |
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| 0 |
| 52 |
| 0 |
| 52 |
Publication requires agreement and written consent from the Sponsor.
| Grade 2 Mild |
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| Grade 2 Mild |
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