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The primary objective of this study is to evaluate the clinical performance of two marketed silicone hydrogel contact lenses in an Indian population in the following areas: physiological characteristics, comfort characteristics and vision characteristics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Lens 1 | Experimental | senofilcon A (Approved contact lens material) |
|
| Test Lens 2 | Active Comparator | lotrafilcon B (Approved contact lens material) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A | Device | One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day |
|
| 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. | 11 days Post fit |
| 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. | 11 days post fit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chennai | Tamil Nadu | 600006 | India |
A total of 54 subjects were enrolled in this study. Of the enrolled subjects all 54 were dispensed a study lens. Of the dispensed 52 completed the study while 2 were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A/ Lotrafilcon B | Subjects randomized to this sequence first wore the senofilcon A lens and then wore the lotrafilcon B lens. |
| FG001 | Lotrafilcon B/Senofilcon A | Subjects randomized to this sequence first wore the lotrafilcon B lens and then wore the senofilcon A lens. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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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 one study lens throughout the duration of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| 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. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | units on a scale | 11 days Post fit |
|
Throughout the duration of the study. Approximately 1 month 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 that wore the senofilcon A lens in either the first or second period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tawnya Wilson O.D. SR. MANAGER GLOBAL CLINICAL SALES EDU | Johnson & Johnson Vision Care Inc. | 443-1834 | TWilson@ITS.JNJ.com |
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| lotrafilcon B | Device | One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day |
|
| 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 |
|
| OG001 |
| Lotrafilcon B |
Subjects that wore the lotrafilcon B lens in either the first or second period of the study. |
|
|
| 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. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | units on a scale | 11 days post fit |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Lotrafilcon B | Subjects that wore the lotrafilcon B lens in either the first or second period of the study. | 0 | 54 | 0 | 54 |
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