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The purpose of this study is to compare lens surface characteristics and comfort between an experimental contact lens and a marketed contact lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| galyfilcon A prototype/marketed galyfilcon A | Other | The galyfilcon A prototype lens worn daily for 12-16 days during the first period then the marketed galyfilcon A lens worn daily for 12-16 days during the second period. |
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| marketed galyfilcon A/galyfilcon A prototype | Other | The marketed galyfilcon A lens worn daily for 12-16 days during the first period then the galyfilcon A prototype lens worn daily for 12-16 days during the second period; during each period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| galyfilcon A prototype lens | Device | Experimental silicone hydrogel contact lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Lens Front Surface Deposits at Day 7 | Deposits on the front surface of each lens were examined by the investigator after 7 days of lens wear, and graded on a 5-point scale; 0 = no deposit, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3 = 16%-25% deposits, and 4 = 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 Vs. grade 2 or higher. | Evaluated at Day 7 |
| Lens Front Surface Deposits at Day 14 | Deposits on the front surface of each lens were examined by the investigator after 14 days of lens wear, and graded on a 5-point scale; 0 = 0% deposits, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3=16%-25% deposits, and 4= 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 vs. grade 2 or higher. | Evaluated at Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Reported Overall Lens Comfort at Day 7 | The overall lens comfort was assessed at Day 7 using the Contact Lens User Experience (CLUE) questionnaire. CLUE 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 |
|---|---|---|---|---|---|---|
| Cupertino | California | United States | ||||
There were five subjects enrolled who were not randomized to a study arm due to exclusion criteria dropping the study enrollment from 185 to 180.
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| ID | Title | Description |
|---|---|---|
| FG000 | Galyfilcon A Prototype/Marketed Galyfilcon A | The galyfilcon A prototype lens worn daily for 12-16 days during the first period then marketed galyfilcon A lens worn daily for 12-16 days during the second period. |
| FG001 | Marketed Galyfilcon A/Galyfilcon A Prototype |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (14 Days) |
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| marketed galyfilcon A lens | Device | Marketed silicone hydrogel contact lens. |
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| Evaluated at Day 7 |
| Subject Reported Overall Lens Comfort at Day 14 | The overall lens comfort was assessed at Day 14 using the CLUE questionnaire. CLUE 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). | Evaluated at Day 14 |
| Huntington Beach |
| California |
| United States |
| Los Angeles | California | United States |
| Pismo Beach | California | United States |
| Jacksonville | Florida | United States |
| Orlando | Florida | United States |
| East Lansing | Michigan | United States |
| Columbus | Ohio | United States |
| Amarillo | Texas | United States |
The marketed galyfilcon A lens worn daily for 12-16 days during the first period then the galyfilcon A prototype lens worn daily for 12-16 days during the second period. |
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| NOT COMPLETED |
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| Period 2 (14 Days) |
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Baseline summary was conducted on all enrolled subjects who have the demographic data. Two enrolled subjects were excluded from the Baseline summary for age and gender categories due to missing demographic data, reducing the count from 185 to 183; one subject was ineligible and the other one withdrew their consent.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All enrolled subjects who have the demographic data and worn at least one study lens. |
| Units | Counts |
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| 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 | Lens Front Surface Deposits at Day 7 | Deposits on the front surface of each lens were examined by the investigator after 7 days of lens wear, and graded on a 5-point scale; 0 = no deposit, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3 = 16%-25% deposits, and 4 = 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 Vs. grade 2 or higher. | Analysis was conducted on subjects who successfully completed the study. | Posted | Mean | Standard Deviation | dichotomized grading scale | Evaluated at Day 7 | eyes | eyes |
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| Secondary | Subject Reported Overall Lens Comfort at Day 7 | The overall lens comfort was assessed at Day 7 using the Contact Lens User Experience (CLUE) questionnaire. CLUE 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 completed the study. | Posted | Mean | Standard Error | CLUE points | Evaluated at Day 7 |
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| Primary | Lens Front Surface Deposits at Day 14 | Deposits on the front surface of each lens were examined by the investigator after 14 days of lens wear, and graded on a 5-point scale; 0 = 0% deposits, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3=16%-25% deposits, and 4= 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 vs. grade 2 or higher. | Analysis was conducted on subjects who successfully completed the study. | Posted | Mean | Standard Deviation | dichtomized grading scale | Evaluated at Day 14 | Contact Lenses | Contact Lenses |
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| Secondary | Subject Reported Overall Lens Comfort at Day 14 | The overall lens comfort was assessed at Day 14 using the CLUE questionnaire. CLUE 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 completed the study. | Posted | Mean | Standard Error | CLUE points | Evaluated at Day 14 |
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Adverse events were recorded when the subjects were exposed to the Investigational lenses.
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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 | All Subjects | All subjects were to wear both lenses during the course of the study. | 0 | 181 | 0 | 181 |
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Publication requires the agreement and written authorization of the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John R. Buch, O.D., M.S., F.A.A.O., Principal Research Optometrist | Johnson & Johnson Vision Care | 1-904-443-1707 | jbuch@its.jnj.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Adverse Event |
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| Unsatisfactory lens fitting |
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| Contact Lenses |
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