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The objective of this study is to assess how various silicone hydrogel lenses perform when worn by subjects who are heavy digital device users.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Marketed Soft Contact Lens (Test) | Experimental | Subjects will be randomized to wear each of three contact lens types (Marketed Soft Contact lens, AIR OPTIX® AQUA, or Biofinity®) for a 4-week period with each lens type. |
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| AIR OPTIX® AQUA | Active Comparator | Subjects will be randomized to wear each of three contact lens types (Marketed Soft Contact lens, AIR OPTIX® AQUA, or Biofinity®) for a 4-week period with each lens type. |
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| Biofinity® | Active Comparator | Subjects will be randomized to wear each of three contact lens types (Marketed Soft Contact lens, AIR OPTIX® AQUA, or Biofinity®) for a 4-week period with each lens type. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marketed Soft Contact lens | Device | Replacement schedule every 2 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Subjective Overall Comfort | Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. Scores range 0-120. | 1-Day Follow-up |
| Subjective Overall Quality of Vision | Subjective Overall quality of vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. Scores range 0-120. | 1-Day Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Waterloo | Ontario | N2I3G1 | Canada |
A total of 52 subjects were enrolled in this study. Of the enrolled subjects 10 subjects did not meet the eligibility criteria and 42 subjects were dispensed study lenses. Of the dispensed subjects 37 completed the study while 5 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A/Lotrafilcon B/Comfilcon A | Subjects randomized to this sequence wore the senofilcon A lens in the first period, the lotrafilcon B lens in the second period and the comfilcon A lens in the third period. |
| FG001 | Senfilcon A/Comfilcon A/Lotrafilcon B | Subjects randomized to this sequence wore the senofilcon A lens in the first period, the comfilcon A lens in the second period and the lotrafilcon B lens in the third period. |
| FG002 | Lotrafilcon B/Comfilcon A/Senofilcon A | Subjects randomized to this sequence wore the lotrafilcon B lens in the first period, the comfilcon A lens in the second period and the senofilcon A lens in the third period. |
| FG003 | Lotrafilcon B/Senofilcon A/Comfilcon A | Subjects randomized to this sequence wore the lotrafilcon B lens in the first period, the senofilcon A lens in the second period and the comfilcon A lens in the third period. |
| FG004 | Comfilcon A/Senofilcon A/ Lotrafilcon B | Subjects randomized to this sequence wore the comfilcon A lens in the first period, the senofilcon A lens in the second period and the lotrafilcon B lens in the third period. |
| FG005 | Comfilcon A/Lotrafilcon B/Senofilcon A | Subjects randomized to this sequence wore the comfilcon A lens in the first period, the lotrafilcon B lens in the second period and the senofilcon A lens in the third period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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All subjects that were dispensed at least one study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects that were dispensed at least 1 study lens. |
| 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 | Subjective Overall Comfort | Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. Scores range 0-120. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | units on a scale | 1-Day Follow-up |
|
Throughout the duration of the study. Approximately 4-weeks per subject.
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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 | Senofilcon A | Subjects wore the senofilcon A lens in any of the three periods during the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Significant Infiltrate Event | Eye disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chantal Coles-Brennan- PRINCIPAL RESEARCH OPTOMETRIST | Johnson & Johnson Vision Care Inc. | 1 904 443 3449 | CColesb@ITS.JNJ.com |
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| AIR OPTIX® AQUA | Device | Replacement schedule every 4 weeks |
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| Biofinity® | Device | Replacement schedule every 4 weeks |
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| Withdrawal by Subject |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Lotrafilcon B | Subjects wore the lotrafilcon B lens in any of the three periods during the study. |
| OG002 | Comfilcon A | Subjects wore the comfilcon A lens in any of the three periods during the study. |
|
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| Primary | Subjective Overall Quality of Vision | Subjective Overall quality of vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. Scores range 0-120. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | units on a scale | 1-Day Follow-up |
|
|
|
| 0 |
| 42 |
| 3 |
| 42 |
| EG001 | Lotrafilcon B | Subjects wore the lotrafilcon B lens in any of the three periods during the study. | 0 | 42 | 0 | 42 |
| EG002 | Comfilcon A | Subjects wore the comfilcon A lens in any of the three periods during the study. | 0 | 42 | 2 | 42 |
| Common Cold | Immune system disorders | Not study related. |
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