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
Not provided
The purpose of this study is to evaluate the comparability of lens fit and lens power of a new contact lens to the lens fit and lens power of two marketed lenses.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| galy A Plus/ galy A / seno A | Other | Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). |
|
| galy A Plus / seno A / galy A | Other | Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 3: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). |
|
| galy A / galy A Plus / seno A | Other | Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). |
|
| galy A / seno A / galy A Plus | Other | Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| galy A Plus | Device | galyfilcon A Plus, BC: 8.3 or 8.7 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Centration Acceptance | Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve. | after 15 minutes of contact lens wear |
| Primary Gaze Lens Movement | Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated. | after 15 minutes of contact lens wear |
| Fit Acceptability | Investigator evaluated lens fit using a six point scale: 5-optimal...3-borderline acceptable...2-unacceptable. Percent of eyes in each category will be evaluated. | after 15 minutes of contact lens wear |
| Measure | Description | Time Frame |
|---|---|---|
| New Lens Power Fit Match to Control Lenses | The lens power fit of test lenses will be compared to control lenses to determine if the power matches. Percent of eyes with exact power fit will be evaluated. | after 15 minutes of contact lens wear |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Farnham | Surrey | GU9 7EN | United Kingdom | |||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Arms, All Interventions | All subjects wore all intervention throughout the course of the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| seno A / galy A / glay A Plus | Other | Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). |
|
| seno A / galy A Plus / galy A | Other | Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: galy A -subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). |
|
| seno A | Device | senofilcon A, BC:8.4 or 8.8 |
|
| galy A | Device | galyfilcon A , BC: 8.3 or 8.7 |
|
| Birmingham |
| B4 7ET |
| United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
All enrolled subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects who where enrolled wore all intervention lenses throughout the course of the study. The specific lenses used include the following: senofilcon A (control) soft contact lens with 8.8 base; senofilcon A (control) soft contact lens with 8.4 base curve; galyfilcon A (control) soft contact lens with 8.7 base curve; galyfilcon A (control) soft contact lens with 8.3 base curve; galyfilcon A Plus (test) soft contact lens with 8.7 base curve; galyfilcon A Plus (test) soft contact lens with 8.3 base curve. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 Centration Acceptance | Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve. | Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm. | Posted | Number | eyes | after 15 minutes of contact lens wear | eyes | eyes |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Primary Gaze Lens Movement | Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated. | Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm. | Posted | Number | percentage of eyes | after 15 minutes of contact lens wear | eyes | eyes |
| ||||||||||||||||||||||||||||||||||||
| Primary | Fit Acceptability | Investigator evaluated lens fit using a six point scale: 5-optimal...3-borderline acceptable...2-unacceptable. Percent of eyes in each category will be evaluated. | Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm. | Posted | Number | percentage of eyes | after 15 minutes of contact lens wear | eyes | eyes |
| ||||||||||||||||||||||||||||||||||||
| Secondary | New Lens Power Fit Match to Control Lenses | The lens power fit of test lenses will be compared to control lenses to determine if the power matches. Percent of eyes with exact power fit will be evaluated. | Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm. | Posted | Number | percentage of eyes | after 15 minutes of contact lens wear | eyes | eyes |
|
Not provided
Not provided
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 | All Arms, All Interventions | All subjects wore all intervention throughout the course of the study. | 0 | 41 | 0 | 41 |
Not provided
Not provided
Publication requires agreement and written authorization from Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathy Osborn, OD | Johnson & Johnson Vision Care | 1-904-443-1032 | kosborn@its.jnj.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
|
| OG004 | Galyfilcon A 8.7 BC | All subjects wore each of the lenses at a point in the study as this was a contralateral study. |
| OG005 | Senofilcon A 8.8 BC | All subjects wore each of the lenses at a point in the study as this was a contralateral study. |
|
|
| OG004 | Galyfilcon A 8.7 BC | All subjects wore each of the lenses at a point in the study as this was a contralateral study. |
| OG005 | Senofilcon A 8.8 BC | All subjects wore each of the lenses at a point in the study as this was a contralateral study. |
|
|
|
|