Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is evaluating the initial fit of toric contact lenses.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A / nelfilcon A / Filcon II 3 | Other | etafilcon A worn first then nelfilcon A worn second with Filcon II 3 worn third. |
|
| nelfilcon A / etafilcon A / Filcon II 3 | Other | nelfilcon A worn first then etafilcon A worn second with Filcon II 3 worn third. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device | A daily wear contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Absolute Lens Rotation | At 1-min after lens insertion, lens orientation position was assessed on a scale of 0-180 degree on both eyes. | At 1-min after lens insertion during Phase I |
| Phase I: Absolute Lens Rotation | Lens orientation position as assessed on a scale of 0-180 on both eyes. | 3 min after lens insertion during Phase I |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Time to Lens Settling | With random insertion and natural blinking, the slit lamp video was used to measure the time of lens settling. | 5 minutes after lens insertion during Phase I |
| Phase I: Number of Blinks Until Settled |
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: Absolute Rotation | Absolute rotation of the lens (degrees) at 1-minute post-fit on both eyes. Filcon II 3 lens was only used for comparison in phase II of the study per study protocol. | 1-minute during Phase II |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Farnham | GU9 7EN | United Kingdom |
Not provided
Subjects are considered to be enrolled and not randomized at baseline. There were 42 subjects enrolled and 2 that were not randomized for a study baseline population of 40.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A/ Nelfilcon A/Filcon II 3 | etafilcon A worn first, nelfilcon A worn second, Filcon II 3 worn third. Only etafilcon A and nelfilcon A were used in phase I of the study per study protocol, with Filcon II 3 being added to the rotation in Phase II (see outcome 5). |
| FG001 | Nelfilcon A/ Etafilcon A/ Filcon II 3 | nelfilcon A worn first, etafilcon A worn second, Filcon II 3 worn third. Only etafilcon A and nelfilcon A were used in phase I of the study per study protocol, with Filcon II 3 being added to the rotation in Phase II (see outcome 5). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects who were enrolled at baseline. |
| 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 | Phase I: Absolute Lens Rotation | At 1-min after lens insertion, lens orientation position was assessed on a scale of 0-180 degree on both eyes. | Subjects included in the analysis were those who were enrolled, randomized, and completed the study. | Posted | Least Squares Mean | 95% Confidence Interval | Degrees | At 1-min after lens insertion during Phase I | eyes | eyes |
|
Not provided
two phases, noted as phase I and phase II
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etafilcon A | Those subjects who wore etafilcon A. (Phase I & II) |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Osborn OD, MS FAAO | Johnson & Johnson Vision Care | 1 904 443-1032 | kosborn@its.jnj.com |
Not provided
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| nelfilcon A | Device | A daily wear contact lens |
|
|
| Filcon II 3 | Device | a daily disposable |
|
|
Number of blinks for the right eye was counted until lens settling using headcam video.
| Baseline to 5 minutes during Phase I |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| eyes |
|
|
| Secondary | Phase I: Time to Lens Settling | With random insertion and natural blinking, the slit lamp video was used to measure the time of lens settling. | Subjects analyzed were those who were enrolled, randomized, and completed the study. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | 5 minutes after lens insertion during Phase I |
|
|
|
| Secondary | Phase I: Number of Blinks Until Settled | Number of blinks for the right eye was counted until lens settling using headcam video. | Subjects analyzed are those who were enrolled, randomized, and completed the study. | Posted | Least Squares Mean | Standard Error | Blinks | Baseline to 5 minutes during Phase I |
|
|
|
| Primary | Phase I: Absolute Lens Rotation | Lens orientation position as assessed on a scale of 0-180 on both eyes. | Analysis was on those subjects who were enrolled, randomized, and completed the study. | Posted | Least Squares Mean | 95% Confidence Interval | Degrees | 3 min after lens insertion during Phase I | eyes | eyes |
|
|
|
| Other Pre-specified | Phase II: Absolute Rotation | Absolute rotation of the lens (degrees) at 1-minute post-fit on both eyes. Filcon II 3 lens was only used for comparison in phase II of the study per study protocol. | Analysis was on those subjects who were enrolled, randomized, and completed the study. | Posted | Mean | Standard Deviation | Degrees | 1-minute during Phase II | eyes | eyes |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Nelfilcon A | Those subjects who wore nelfilcon A. (Phase I & II) | 0 | 40 | 0 | 40 |
| EG002 | Filcon II 3 | Those who wore Filcon II 3 during Phase II | 0 | 40 | 0 | 40 |
Not provided