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Single-visit, unmasked, non-dispensing study where subjects will wear three different lenses bilaterally in one visit, each lens being worn for approximately 30-60 minutes. Subjects will complete a questionnaire for each study lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Sequence A, B, C | Active Comparator | Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses. |
|
| Group Sequence B, C, A | Active Comparator | Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses. |
|
| Group Sequence C, A, B | Active Comparator | Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses. |
|
| Group Sequence C, B, A | Active Comparator | Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etafilcon A Design 1 (Test 1) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| CLUE Handling | CLUE Handling is assessed 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 +/- 3XSD). | 30 Minutes Post Insertion |
| Visual Performance (LogMar) | Distance time controlled Visual Performance (LogMAR) was assessed for each subject eye under bright-illumination high-contrast lighting conditions at 4m using an ETDRS chart. The average visual performance (LogMAR) was reported for each study lens. | 30 Minutes Post Insertion |
| Percentage of Eyes With Acceptable Mechanical Lens Fit | Mechanical lens fit will be assessed for each subject and eye using a slit lamp. Lens fit is a binary response and 'Yes' = Acceptable Fit and 'No' = Unacceptable Fit. Lens fit is assessed using Lens centration, limbal exposure, primary gaze movement, up-gaze movement, edge lift, lens tightness. Unacceptable fit will be declared if there is any of the following present: limbal exposure, edge lift, excessive movement in primary or up-gaze or insufficient movement in primary gaze and up-gaze. The Percentage of subject eyes with acceptable lens fit will be reported. | 30 Minutes Post Insertion |
| Percentage of Eyes With Acceptable Cosmetic Lens Fit | Cosmetic lens fitting is assessed for each subject eye in the primary gaze position without a slit lamp. Cosmetic lens fit is a binary response and is reported as acceptable or unacceptable. The Percentage of subject eyes with acceptable cosmetic lens fitting is reported. | 30 Minutes Post Insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Polytechnic University | Hong Hom | Kowloon | Hong Kong |
A total of 116 subjects were enrolled into the study. Of the enrolled subjects 15 were not dispensed a study lens. A total of 101 subjects were dispensed a study lens. Of the dispensed subjects 1 was discontinued and 100 subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test1/Test2/Control | Subjects that received Test lens 1 during the first period, Test lens 2 during the second period and the Control lens during the third period. |
| FG001 | Test1/Control/Test2 | Subjects that received Test lens 1 during the first period, the Control lens during the second period and Test lens 2 during the third period. |
| FG002 | Test2/Test1/Control | Subjects that received Test lens 2 during the first period, Test lens 1 during the second period and the Control lens during the third period. |
| FG003 | Test2/Control/Test1 | Subjects that received Test lens 2 during the first period, the Control lens during the second and the Test 1 lens during the third period. |
| FG004 | Control/Test1/Test2 | Subjects that received the Control lens during the first period, Test lens 1 during the second period and Test lens 2 during the third period. |
| FG005 | Control/Test2/Test1 | Subjects that received the Control lens during the first period, Test 2 lens during the second period and Test lens 1 during 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 one study lens. |
| 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 | CLUE Handling | CLUE Handling is assessed 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 +/- 3XSD). | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a scale | 30 Minutes Post Insertion |
|
Throughout the duration of the study. Approximately 3 hours 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 | Test1 | Subjects that wore the Test 1 lens during any of the 3 study periods. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meredith Bishop, OD, MS, FAAO | Johnson & Johnson Vision | 904-443-1396 | MBishop4@its.jnj.com |
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| Group Sequence A, C, B | Active Comparator | Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses. |
|
| Group Sequence B, A, C | Active Comparator | Subjects will wear Test 1, Test 2, and Control contact lenses in order according to the randomization sequence assigned for approximately 30-60 minutes each, with a 5-minute wash-out period between lenses. |
|
| Etafilcon A Design 2 (Test 2) | Device |
|
| Etafilcon A (Control) | Device |
|
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | Participants |
|
| OG001 |
| Test 2 |
Subjects that wore the Test 2 lens during any of the 3 study periods. |
| OG002 | Control | Subjects that wore the control lens during any of the 3 study periods. |
|
|
| Primary | Visual Performance (LogMar) | Distance time controlled Visual Performance (LogMAR) was assessed for each subject eye under bright-illumination high-contrast lighting conditions at 4m using an ETDRS chart. The average visual performance (LogMAR) was reported for each study lens. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | LogMAR | 30 Minutes Post Insertion | Eyes | Eyes |
|
|
|
| Primary | Percentage of Eyes With Acceptable Mechanical Lens Fit | Mechanical lens fit will be assessed for each subject and eye using a slit lamp. Lens fit is a binary response and 'Yes' = Acceptable Fit and 'No' = Unacceptable Fit. Lens fit is assessed using Lens centration, limbal exposure, primary gaze movement, up-gaze movement, edge lift, lens tightness. Unacceptable fit will be declared if there is any of the following present: limbal exposure, edge lift, excessive movement in primary or up-gaze or insufficient movement in primary gaze and up-gaze. The Percentage of subject eyes with acceptable lens fit will be reported. | Subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of eyes | 30 Minutes Post Insertion | Eyes | Eyes |
|
|
|
| Primary | Percentage of Eyes With Acceptable Cosmetic Lens Fit | Cosmetic lens fitting is assessed for each subject eye in the primary gaze position without a slit lamp. Cosmetic lens fit is a binary response and is reported as acceptable or unacceptable. The Percentage of subject eyes with acceptable cosmetic lens fitting is reported. | Subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of eyes | 30 Minutes Post Insertion | Eyes | Eyes |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Test2 | Subjects that wore the Test 2 lens during any of the 3 periods. | 0 | 100 | 0 | 100 |
| EG002 | Control | Subjects that wore the control lens during any of the 3 study periods. | 0 | 101 | 0 | 101 |
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