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| ID | Type | Description | Link |
|---|---|---|---|
| ETOR-507(under GNR-011) |
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| Name | Class |
|---|---|
| Visioncare Research Ltd. | OTHER |
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The purpose of this study is to determine the relative performance of a new toric soft contact lens against three toric contact lens currently available in market, specifically with orientation and visual acuity when head is tilted at 90 degrees.
Non-dispensing single-masked (subject-masked), randomised, 1-visit controlled study, ~2 hour duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A | Active Comparator | One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. Period 1: lotrafilcon B /period 2: senofilcon A / period 3: balafilcon A / period 4: omafilcon A |
|
| Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A | Active Comparator | One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: omafilcon A / period 3: senofilcon A / period 4: balafilcon A |
|
| Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A | Active Comparator | One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: balafilcon A / period 3: senofilcon A / period 4: omafilcon A |
|
| Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A | Device | toric contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Orientation During Head Tilt. | Degree of lens rotation on the eye with the head tilted. | after fit of each of the four lens insertions |
| Visual Acuity During Head Tilt | logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | after each of the four lens insertions |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Lens Rotation in Superior Gaze. | Degree of lens rotation while participant is gazing up. | After each of the four lens insertions |
| Degree of Lens Rotation in Superior-temporal Gaze. | Degree of lens rotation while participant is gazing up and out(towards the temple). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Graeme Young, BSc, MPhil | Visioncare Research Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visioncare Research Ltd. | Farnham | GU9 7EN | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. |
| FG001 | Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. |
| FG002 | Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. |
| FG003 | Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. |
| FG004 | Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. |
| FG005 | Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. |
| FG006 | Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. |
| FG007 | Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. |
| FG008 | Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. |
| FG009 | Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. |
| FG010 | Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. |
| FG011 | Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - First Intervention |
| |||||||||||||
| Period 2 - Second Intervention |
| |||||||||||||
| Period 3 - Third Intervention |
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| Period 4 - Fourth Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | Summary for overall study population |
| 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 | Lens Orientation During Head Tilt. | Degree of lens rotation on the eye with the head tilted. | Only participants who completed the study per protocol. Some participants had missing data for some lenses. | Posted | Mean | Standard Deviation | Degree of rotation | after fit of each of the four lens insertions |
|
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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 | Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kurt Moody, OD FAAO | Vistakon | 904-443-3088 | kmoody1@its.jnj.com |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D000072458 | Orientation, Spatial |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D013037 | Spatial Behavior |
| D001519 | Behavior |
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One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: balafilcon A |
|
| Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B | Active Comparator | One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: omafilcon A / period 3: balafilcon A / period 4: lotrafilcon B |
|
| Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A | Active Comparator | One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: balafilcon A / period 3: lotrafilcon B / period 4: omafilcon A |
|
| Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A | Active Comparator | One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: omafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: balafilcon A |
|
| Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A | Active Comparator | One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: omafilcon A |
|
| Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A | Active Comparator | One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: senofilcon A |
|
| Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A | Active Comparator | One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: lotrafilcon B / period 4: omafilcon A |
|
| Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B | Active Comparator | One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: omafilcon A / period 4: lotrafilcon B |
|
| Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A | Active Comparator | One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: omafilcon A / period 3: lotrafilcon B / period 4: senofilcon A |
|
| balafilcon A toric | Device | toric contact lens |
|
| lotrafilcon B toric | Device | toric contact lens |
|
| omafilcon A | Device | toric contact lens |
|
| After each of 4 lens insertions., |
| Degree of Lens Rotation in Superior-nasal Gaze. | Degree of lens rotation while participant is gazing up and in(towards the nose). | After each of the four lens insertions |
| Degree of Lens Rotation in Temporal Gaze. | Degree of lens rotation while participant is gazing out(towards the temple). | After each of the four lens insertions |
| Degree of Lens Rotation in Nasal Gaze. | Degree of lens rotation while participant is gazing in(towards the nose). | After each of the four lens insertions |
| Degree of Lens Rotation Inferior-temporal Gaze. | Degree of lens rotation while participant is gazing down and out. | After each of the four lens insertions |
| Degree of Lens Rotation in Inferior-nasal Gaze. | Degree of lens rotation while participant is gazing down and in. | After each of the four lens insertions |
| Degree of Lens Rotation in Inferior Gaze. | Degree of lens rotation while participant is gazing down. | After each of the four lens insertions |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Lotrafilcon B Toric |
lotrafilcon B toric worn in either the first, second, third, or fourth periods. |
| OG003 | Omafilcon A Toric | omafilcon A toric worn in either the first, second, third, or fourth periods. |
|
|
|
| Primary | Visual Acuity During Head Tilt | logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | Only participants who completed the study per protocol. Some participants had missing data for some of the lenses. | Posted | Mean | Standard Deviation | logMAR units | after each of the four lens insertions |
|
|
|
|
| Secondary | Degree of Lens Rotation in Superior Gaze. | Degree of lens rotation while participant is gazing up. | Only participants who completed the study per protocol. Some participants had missing data for some lenses. | Posted | Mean | Standard Deviation | Degree of rotation | After each of the four lens insertions |
|
|
|
|
| Secondary | Degree of Lens Rotation in Superior-temporal Gaze. | Degree of lens rotation while participant is gazing up and out(towards the temple). | Only participants who completed the study per protocol. Some participants had missing data for some lenses. | Posted | Mean | Standard Deviation | Degree of rotation | After each of 4 lens insertions., |
|
|
|
|
| Secondary | Degree of Lens Rotation in Superior-nasal Gaze. | Degree of lens rotation while participant is gazing up and in(towards the nose). | Only participants who completed the study per protocol. Some participants had missing data for some lenses. | Posted | Mean | Standard Deviation | Degree of rotation | After each of the four lens insertions |
|
|
|
|
| Secondary | Degree of Lens Rotation in Temporal Gaze. | Degree of lens rotation while participant is gazing out(towards the temple). | Only participants who completed the study per protocol. Some participants had missing data for some lenses. | Posted | Mean | Standard Deviation | Degree of rotation | After each of the four lens insertions |
|
|
|
|
| Secondary | Degree of Lens Rotation in Nasal Gaze. | Degree of lens rotation while participant is gazing in(towards the nose). | Only participants who completed the study per protocol. Some participants had missing data for some lenses. | Posted | Mean | Standard Deviation | Degree of rotation | After each of the four lens insertions |
|
|
|
|
| Secondary | Degree of Lens Rotation Inferior-temporal Gaze. | Degree of lens rotation while participant is gazing down and out. | Only participants who completed the study per protocol. Some participants had missing data for some of the lenses. | Posted | Mean | Standard Deviation | Degree of rotation | After each of the four lens insertions |
|
|
|
|
| Secondary | Degree of Lens Rotation in Inferior-nasal Gaze. | Degree of lens rotation while participant is gazing down and in. | Only participants who completed the study per protocol. Some participants had missing data for some of the lenses. | Posted | Mean | Standard Deviation | Degree of rotation | After each of the four lens insertions |
|
|
|
|
| Secondary | Degree of Lens Rotation in Inferior Gaze. | Degree of lens rotation while participant is gazing down. | Only participants who completed the study per protocol. Some participants had missing data for some of the lenses. | Posted | Mean | Standard Deviation | Degree of rotation | After each of the four lens insertions |
|
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | 0 | 2 | 0 | 1 |
| EG002 | Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | 0 | 1 | 0 | 1 |
| EG003 | Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | 0 | 1 | 0 | 1 |
| EG004 | Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | 0 | 1 | 0 | 1 |
| EG005 | Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | 0 | 1 | 0 | 1 |
| EG006 | Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | 0 | 1 | 0 | 1 |
| EG007 | Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | 0 | 1 | 0 | 1 |
| EG008 | Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | 0 | 1 | 0 | 1 |
| EG009 | Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | 0 | 1 | 0 | 1 |
| EG010 | Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | 0 | 1 | 0 | 1 |
| EG011 | Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A | All lenses were toric lenses. The order of lenses in the title relates to the period of administration. | 0 | 1 | 0 | 1 |
The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.
Alternative hypothesis was senofilcon A toric was superior to lotrafilcon B toric by having a lower logMAR score |
| t-test, 1 sided |
| 0.052 |
| Mean Difference (Final Values) |
| -0.06 |
| Standard Deviation |
| 0.09 |
| 95 |
Mean difference was senofilcon A minus lotrafilcon B |
| No |
| Superiority or Other |
| Alternative hypothesis was senofilcon A toric was superior to omafilcon A toric by having a lower logMAR score | t-test, 1 sided | 0.015 | Mean Difference (Final Values) | -0.13 | Standard Deviation | 0.14 | 95 | Mean difference was senofilcon A minus omafilcon A | No | Superiority or Other |
| 0.73 |
| Mean Difference (Final Values) |
| -0.3 |
| Standard Deviation |
| 3.5 |
| 95 |
Mean difference is senofilcon A minus lotrafilcon B |
| No |
| Superiority or Other |
| t-test, 1 sided | 0.044 | Mean Difference (Final Values) | -3.3 | Standard Deviation | 4.4 | 95 | Mean difference was senofilcon A minus omafilcon A | No | Superiority or Other |
| 0.31 |
| Mean Difference (Final Values) |
| 1.4 |
| Standard Deviation |
| 4.7 |
| 95 |
Mean difference is senofilcon A minus lotrafilcon B |
| No |
| Superiority or Other |
| t-test, 1 sided | 0.44 | Mean Difference (Final Values) | -1.5 | Standard Deviation | 5.9 | 95 | Mean difference is senofilcon A minus omafilcon A | No | Superiority or Other |
| 0.68 |
| Mean Difference (Final Values) |
| -0.7 |
| Standard Deviation |
| 6.3 |
| 95 |
Mean difference is senofilcon A minus lotrafilcon B |
| No |
| Superiority or Other |
| t-test, 1 sided | 0.78 | Mean Difference (Final Values) | -0.4 | Standard Deviation | 7.6 | 95 | Mean difference is senofilcon A minus omafilcon A | No | Superiority or Other |
| 0.31 |
| Mean Difference (Final Values) |
| 1.3 |
| Standard Deviation |
| 4.3 |
| 95 |
Mean difference is senofilcon A minus lotrafilcon B |
| No |
| Superiority or Other |
| t-test, 1 sided | 0.16 | Median Difference (Final Values) | -3.0 | Standard Deviation | 6.3 | 95 | Mean difference is senofilcon A minus omafilcon A | No | Superiority or Other |
| 0.47 |
| Mean Difference (Final Values) |
| 0.8 |
| Standard Deviation |
| 3.9 |
| 95 |
Mean difference is senofilcon A minus lotrafilcon B |
| No |
| Superiority or Other |
| t-test, 1 sided | 0.38 | Mean Difference (Final Values) | -1.0 | Standard Deviation | 3.6 | 95 | Mean difference is senofilcon A minus omafilcon A | No | Superiority or Other |
| 0.89 |
| Mean Difference (Final Values) |
| 0.2 |
| Standard Deviation |
| 5.0 |
| 95 |
Mean difference is senofilcon A minus lotrafilcon B |
| No |
| Superiority or Other |
| t-test, 1 sided | 0.56 | Mean Difference (Final Values) | 1.1 | Standard Deviation | 5.8 | 95 | Mean difference is senofilcon A minus omafilcon A | No | Superiority or Other |
| 0.0049 |
| Mean Difference (Final Values) |
| -2.9 |
| Standard Deviation |
| 3.1 |
| 95 |
Mean difference is senofilcon A minus lotrafilcon B |
| No |
| Superiority or Other |
| t-test, 1 sided | 0.0058 | Mean Difference (Final Values) | -6.4 | Standard Deviation | 5.6 | 95 | Mean difference is senofilcon A minus omafilcon A | No | Superiority or Other |
| 0.85 |
| Mean Difference (Final Values) |
| -0.3 |
| Standard Deviation |
| 6.0 |
| 95 |
Mean difference is senofilocon A minus lotrafilcon B |
| No |
| Superiority or Other |
| t-test, 1 sided | 0.73 | Mean Difference (Final Values) | 0.3 | Standard Deviation | 2.6 | 95 | Mean difference is senofilcon A minus omifilcon A | No | Superiority or Other |