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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/comfilcon A | Other | The galyfilcon A prototype lenses are worn during first period and comfilcon A lenses worn during second period. Each period consists of daily lens wear for one week. |
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| comfilcon A/galyfilcon A prototype | Other | The comfilcon A lenses are worn during first period and galyfilcon A prototype lenses worn during 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity Monocular | Snellen monocular visual acuity measurement was measured in both eyes that wore lenses for one week and came in for the evaluation with an inserted lens. | after 7 +/- 1 days of lens wear |
| Visual Acuity Binocular | Snellen binocular visual acuity measurement | after 7 +/- 1 days of lens wear |
| Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. | The contract Lens Experience (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. | after 7 +/-1 days of lens wear |
| Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire. | 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 7 +/- 1 days 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 7 days 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 | ||||
Fifty-three (53) subjects enrolled, one(1) subject was discontinued and fifty-two (52) completed the study.
This study was a four (4) site, bilateral crossover study. Data were collected in three (3) visits (initial, 1 wk follow-up, and final visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Galyfilcon A (Test)/Comfilcon A (Control) | Each subject wore the assigned lens type for 7 +/- 1 days, according to the randomization scheme. |
| FG001 | Comfilcon A (Control)/Galyfilcon A (Test) | Each subject wore the assigned lens type for 7 +/- 1 days, according to the randomization scheme. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (7 +/- Days) |
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| Period 2 (7 +/- 1 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All enrolled subjects at baseline. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 was measured in both eyes that wore lenses for one week and came in for the evaluation with an inserted lens. | Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study. | Posted | Number | eyes | after 7 +/- 1 days 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/Comfilcon A | All enrolled subjects were to wear both lenses through the course of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Buch, OD, MS, FAAO | Johnson & Johnson Vision Care | 1 904 443-1707 | jbuch@its.jnj.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| comfilcon A | Device | silicone hydrogel contact lens |
|
|
| after 7 days of lens wear |
| Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. | 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 |
| Orlando |
| Florida |
| United States |
| Fincastle | Virginia | United States |
| Salem | Virginia | United States |
| NOT COMPLETED |
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| Participants |
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| 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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| Primary | Visual Acuity Binocular | Snellen binocular visual acuity measurement | Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study. | Posted | Number | participants | after 7 +/- 1 days of lens wear |
|
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|
| Primary | Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. | The contract Lens Experience (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. | Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study. | Posted | Least Squares Mean | Standard Error | CLUE score | after 7 +/-1 days 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. | Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study. | Posted | Number | eyes | after 7 days of lens wear | eyes | eyes |
|
|
|
| Primary | Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire. | 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. | Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study. | Posted | Least Squares Mean | Standard Error | CLUE score | after 7 +/- 1 days of lens wear |
|
|
|
| Secondary | Bulbar Redness | Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe. | Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study. | Posted | Number | eyes | after 7 days of lens wear | eyes | eyes |
|
|
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| Secondary | Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. | 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. | Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study. | Posted | Mean | Standard Deviation | CLUE score | 10 minutes after lens insertion at time of initial lens fitting |
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| 0 |
| 53 |
| 0 |
| 53 |
Publication requires agreement and written consent from the Sponsor.
| 20/20 binocular |
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| 20/25 binocular |
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| 20/30 binocular |
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| Grade 2 = Mild redness |
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| Grade 2 = Mild redness |
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