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Primary objective is to evaluate the efficacy of single-dose treatment with GSK1358820 compared with non-treatment in patients with strabismus based on angles of strabismus in the primary position.
Primary objective is to evaluate the efficacy of single-dose treatment with GSK1358820 compared with non-treatment in patients with strabismus based on angles of strabismus in the primary position. Secondary objective is to evaluate the efficacy and safety of repeated-dose treatment with GSK1358820 in patients with strabismus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-treatment (10-20 PD) | No Intervention | Receive no treatment on Week 0 | |
| GSK1358820 1.25 U (10-20 PD) | Active Comparator | Receive 1.25 U of GSK1358820 on Week 0 |
|
| GSK1358820 2.5 U (10-20 PD) | Active Comparator | Receive 2.5 U of GSK1358820 on Week 0 |
|
| Non-treatment (20-50 PD) | No Intervention | Receive no treatment on Week 0 | |
| GSK1358820 2.5 U (20-50 PD) | Active Comparator | Receive 2.5 U of GSK1358820 on Week 0 |
|
| GSK1358820 5.0 U (20-50 PD) | Active Comparator | Receive 5.0 U of GSK1358820 on Week 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1358820 | Drug | IM injection of Botulinum Toxin Type A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC) | The strabismus angle in the primary position was measured using the alternative prism cover test (APCT). The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 meters [m]) and the near-view strabismus angle (measured at a distance of 33 centimeters [cm]). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the value at Week 4 minus the value at Baseline. | Baseline and Week 4 of the FTP |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 1 After the Initial Injection of the FTP in Observed Cases (OC) | The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the value at Week 1minus the value at Baseline. |
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Inclusion Criteria:
<At the start of screening period>
Exclusion Criteria:
<At the start of screening period>
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aichi | 494-0001 | Japan | |||
| GSK Investigational Site |
A total of 41 participants with horizontal strabismus meeting the selection criteria were divided into two strata in terms of the mean of the distant-view strabismus angle and the near-view strabismus angle in the primary position: >=10 prism dioptre (PD) to <20 PD as Strata 1 and >=20 PD to <50 PD as Strata 2.
The study consisted of a Screening Period (1-2 weeks), the First Treatment Period (12-52 weeks), and the Second Treatment Period (24 weeks). In this summary, data are presented for participants who completed Week 24 of the First Treatment Period.
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| ID | Title | Description |
|---|---|---|
| FG000 | BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 | Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections. |
| FG001 | BSA >=10 PD and <20 PD: GSK1358820 1.25 U | Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections. |
| FG002 | BSA >=10 PD and <20 PD: GSK1358820 2.5 U | Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections. |
| FG003 | BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 | Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections. |
| FG004 | BSA >=20 PD and <50 PD: GSK1358820 2.5 U | Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections. |
| FG005 | BSA >=20 PD and <50 PD: GSK1358820 5.0 U | Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Treatment Period |
|
| ||||||||||||||||||
| Second Treatment Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-treatment, Then GSK1358820 | Participants (par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD or with a BSA >=20 PD and <50 PD received no treatment from the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U), 2.5 U, or 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections. |
| 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 | Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC) | The strabismus angle in the primary position was measured using the alternative prism cover test (APCT). The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 meters [m]) and the near-view strabismus angle (measured at a distance of 33 centimeters [cm]). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the value at Week 4 minus the value at Baseline. | Full Analysis Set (FAS1) Population: all participants who were randomized and had at least one post-Baseline efficacy assessment. Values were summarized for OC of the FTP without imputation of missing values. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | prism dioptre | Baseline and Week 4 of the FTP |
|
Serious adverse events (SAEs) and non-serious adverse events (AEs) reported from the start of randomization up to Week 24 of the FTP are summarized.
SAEs and non-serious AEs were summarized for members of the Safety Population (SP1), comprised of all randomized participants in the FTP.
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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 | Non-treatment | Participants (par) with a BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received no treatment from the start of the First Treatment Period (FTP). Par were re-evaluated at Week 4 and Weeks 12-24. Par who did not meet the injection criteria at any time point remained in the FTP group and were observed up to study Week 52. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Strabismus | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eyelid ptosis | Eye disorders | MedDRA 16.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D013285 | Strabismus |
| ID | Term |
|---|---|
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
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|
| Baseline and Week 1 of the FTP |
| Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP | The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for the observed cases for the change in the strabismus angle in the primary position from Baseline at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in the non-treatment groups). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP |
| Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP) | The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52) |
| Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP | The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The absolute values of the strabismus angle in the primary position at Week 1 and Week 4 of the FTP were summarized for observed cases without imputation of missing values. | Weeks 1 and 4 of the FTP |
| Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP | The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The absolute values of the strabismus angle in the primary position were summarized for observed cases at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in the non-treatment groups). | Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP |
| Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP | The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. | Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52) |
| Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP | The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for observed cases for the percent change from Baseline in the strabismus angle in the primary position at Week 1and Week 4 after the initial injection in the FTP. Percent change from Baseline in the strabismus angle was calculated as: absolute angle ([strabismus angle at Baseline minus strabismus angle after the final injection] divided by the absolute strabismus angle at Baseline) multiplied by 100. | Baseline and Weeks 1 and 4 of the FTP |
| Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP | The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for observed cases for percent change from Baseline in the strabismus angle in the primary position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in non-treatment groups; up to a maximum of 52 weeks of the FTP). Percent change from Baseline in the strabismus angle was calculated as: (absolute angle [strabismus angle at Baseline minus the strabismus angle after the final injection] divided by the absolute strabismus angle at Baseline) multiplied by | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 of the FTP |
| Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP | The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. Percent change from Baseline in the strabismus angle was calculated as: (absolute angle [strabismus angle at Baseline minus the strabismus angle after the final injection] divided by the absolute strabismus angle at Baseline) multiplied by 100. | Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52) |
| Duration of Effect | Duration of effect is defined as the number of days after the final injection of the FTP (after randomization in the non-treatment groups) until the date of the first recording of a value smaller than 50% in percent correction compared to the maximum change in the strabismus angle in the primary position. The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Percent correction compared to the maximum change in the strabismus angle was calculated as: (absolute angle [strabismus angle at Baseline minus the strabismus angle after injection]/absolute angle [strabismus angle at Baseline minus the strabismus angle at maximum change]) multiplied by 100. | Up to Week 48 after the final injection of the FTP (up to Study Week 52) |
| Severity of Duction Limitation at Weeks 1 and 4 of the FTP | The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction is limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. | Week 1 and Week 4 of the FTP |
| Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP | The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction is limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. | Weeks 1, 4, 8, 12, 16, 20, and 24 after the final injection of the FTP (up to a maximum of 52 weeks of the FTP) |
| Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP | The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. All participants with paralytic strabismus did not receive a second injection so there were no participants to analyse for this outcome measure. | Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52) |
| Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP | The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline and Weeks 1 and 4 of the FTP |
| Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP | The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP (up to a maximum of 52 weeks of the FTP) |
| Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP | The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. All participants with paralytic strabismus did not receive a second injection so there were no participants to analyse for this outcome measure. | Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52) |
| Fukuoka |
| 812-0011 |
| Japan |
| GSK Investigational Site | Hyōgo | 663-8501 | Japan |
| GSK Investigational Site | Kagoshima | 890-0046 | Japan |
| GSK Investigational Site | Kanagawa | 252-0375 | Japan |
| GSK Investigational Site | Miyazaki | 880-0035 | Japan |
| GSK Investigational Site | Miyazaki | 885-0051 | Japan |
| GSK Investigational Site | Osaka | 535-0021 | Japan |
| GSK Investigational Site | Osaka | 569-8686 | Japan |
| GSK Investigational Site | Shizuoka | 431-3192 | Japan |
| GSK Investigational Site | Tokyo | 101-0062 | Japan |
| GSK Investigational Site | Tokyo | 134-0088 | Japan |
| GSK Investigational Site | Yamaguchi | 750-0061 | Japan |
| Protocol Violation |
|
| Met Protocol-defined Stopping Criteria |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | GSK1358820 1.25 U | Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections. |
| BG002 | GSK1358820 2.5 U | Par with a BSA >=10 PD and <20 PD or with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections. |
| BG003 | GSK1358820 5.0 U | Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 |
Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections. |
| OG001 | BSA >=10 PD and <20 PD: GSK1358820 1.25 U | Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections. |
| OG002 | BSA >=10 PD and <20 PD: GSK1358820 2.5 U | Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections. |
| OG003 | SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 | Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections. |
| OG004 | BSA >=20 PD and <50 PD: GSK1358820 2.5 U | Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections. |
| OG005 | BSA >=20 PD and <50 PD: GSK1358820 5.0 U | Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections. |
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| Secondary | Change From Baseline in the Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 1 After the Initial Injection of the FTP in Observed Cases (OC) | The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the value at Week 1minus the value at Baseline. | FAS1 Population | Posted | Mean | Standard Deviation | prism dioptre | Baseline and Week 1 of the FTP |
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| Secondary | Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP | The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for the observed cases for the change in the strabismus angle in the primary position from Baseline at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in the non-treatment groups). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | FAS1 Population | Posted | Mean | Standard Deviation | prism dioptre | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP |
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| Secondary | Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP) | The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | FAS2 Population: all participants who were included in the FAS1 Population, received reinjection of the investigational product, and had at least one efficacy assessment after the reinjection | Posted | Mean | Standard Deviation | prism dioptre | Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52) |
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| Secondary | Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP | The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The absolute values of the strabismus angle in the primary position at Week 1 and Week 4 of the FTP were summarized for observed cases without imputation of missing values. | FAS1 Population | Posted | Mean | Standard Deviation | prism dioptre | Weeks 1 and 4 of the FTP |
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| Secondary | Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP | The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The absolute values of the strabismus angle in the primary position were summarized for observed cases at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in the non-treatment groups). | FAS1 Population | Posted | Mean | Standard Deviation | prism dioptre | Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP |
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| Secondary | Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP | The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. | FAS2 population. | Posted | Mean | Standard Deviation | prism dioptre | Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52) |
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| Secondary | Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP | The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for observed cases for the percent change from Baseline in the strabismus angle in the primary position at Week 1and Week 4 after the initial injection in the FTP. Percent change from Baseline in the strabismus angle was calculated as: absolute angle ([strabismus angle at Baseline minus strabismus angle after the final injection] divided by the absolute strabismus angle at Baseline) multiplied by 100. | FAS1 Population | Posted | Mean | Standard Deviation | Percent change in prism dioptre | Baseline and Weeks 1 and 4 of the FTP |
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| Secondary | Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP | The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for observed cases for percent change from Baseline in the strabismus angle in the primary position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in non-treatment groups; up to a maximum of 52 weeks of the FTP). Percent change from Baseline in the strabismus angle was calculated as: (absolute angle [strabismus angle at Baseline minus the strabismus angle after the final injection] divided by the absolute strabismus angle at Baseline) multiplied by | FAS1 Population | Posted | Mean | Standard Deviation | Percent change in prism dioptre | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 of the FTP |
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| Secondary | Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP | The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. Percent change from Baseline in the strabismus angle was calculated as: (absolute angle [strabismus angle at Baseline minus the strabismus angle after the final injection] divided by the absolute strabismus angle at Baseline) multiplied by 100. | FAS2 Population | Posted | Mean | Standard Deviation | Percent change in prism dioptre | Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52) |
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| Secondary | Duration of Effect | Duration of effect is defined as the number of days after the final injection of the FTP (after randomization in the non-treatment groups) until the date of the first recording of a value smaller than 50% in percent correction compared to the maximum change in the strabismus angle in the primary position. The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Percent correction compared to the maximum change in the strabismus angle was calculated as: (absolute angle [strabismus angle at Baseline minus the strabismus angle after injection]/absolute angle [strabismus angle at Baseline minus the strabismus angle at maximum change]) multiplied by 100. | FAS1 Population | Posted | Median | 95% Confidence Interval | Days | Up to Week 48 after the final injection of the FTP (up to Study Week 52) |
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| Secondary | Severity of Duction Limitation at Weeks 1 and 4 of the FTP | The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction is limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. | FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population. | Posted | Mean | Standard Deviation | Scores on a scale | Week 1 and Week 4 of the FTP |
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| Secondary | Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP | The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction is limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. | FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population. | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 1, 4, 8, 12, 16, 20, and 24 after the final injection of the FTP (up to a maximum of 52 weeks of the FTP) |
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| Secondary | Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP | The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. All participants with paralytic strabismus did not receive a second injection so there were no participants to analyse for this outcome measure. | FAS2 Population | Posted | Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52) |
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| Secondary | Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP | The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Weeks 1 and 4 of the FTP |
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| Secondary | Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP | The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP (up to a maximum of 52 weeks of the FTP) |
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| Secondary | Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP | The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. All participants with paralytic strabismus did not receive a second injection so there were no participants to analyse for this outcome measure. | FAS2 Population | Posted | Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52) |
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| 0 |
| 13 |
| 1 |
| 13 |
| EG001 | Non-treatment, Then GSK1358820 | Par with a BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received no treatment from the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U), 2.5 U, or 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections. | 0 | 13 | 8 | 13 |
| EG002 | GSK1358820 1.25 U | Par with a BSA greater than or equal to 10 PD and less than 20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections. | 0 | 4 | 1 | 4 |
| EG003 | GSK1358820 2.5 U | Participants with BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections. | 1 | 13 | 6 | 13 |
| EG004 | GSK1358820 5.0 U | Par with a BSA greater than or equal to 20 PD and less than 50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections. | 0 | 11 | 6 | 11 |
| Conjunctival haemorrhage | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Diplopia | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Eye movement disorder | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Strabismus | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Conjunctival deposit | Eye disorders | MedDRA | Systematic Assessment |
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| Conjunctivitis allergic | Eye disorders | MedDRA | Systematic Assessment |
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| Corneal erosion | Eye disorders | MedDRA | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA | Systematic Assessment |
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| Ophthalmoplegia | Eye disorders | MedDRA | Systematic Assessment |
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| Punctate keratitis | Eye disorders | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
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| Helicobacter infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Therapeutic response increased | General disorders | MedDRA | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Periorbital contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA | Systematic Assessment |
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| Calculus urinary | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Vertigo positional | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| Week 4, n=3, 4, 2, 10, 10, 11 |
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| Week 8, n=3, 4, 2, 10, 10, 10 |
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| Week 12, n=3, 4, 2, 10, 10, 10 |
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| Week 16, n=2, 4, 2, 9, 10, 10 |
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| Week 20, n=2, 4, 0, 7, 9, 9 |
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| Week 24, n=1, 3, 0, 5, 8, 9 |
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| Week 28, n=1, 3, 0, 4, 7, 8 |
|
| Week 32, n=1, 3, 0, 4, 7, 8 |
|
| Week 36, n=1, 3, 0, 4, 7, 8 |
|
| Week 40, n=1, 3, 0, 4, 7, 8 |
|
| Week 44, n=1, 3, 0, 4, 7, 8 |
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| Week 48, n=1, 3, 0, 4, 7, 8 |
|
| Week 4, n=2, 1, 2, 6, 3, 1 |
|
| Week 8, n=2, 1, 2, 6, 3, 0 |
|
| Week 12, n=2, 1, 2, 6, 3, 1 |
|
| Week 16, n=1, 1, 2, 6, 3, 0 |
|
| Week 20, n=2, 1, 2, 6, 3, 0 |
|
| Week 24, n=1, 1, 2, 6, 3, 0 |
|
| Week 4, n=3, 4, 2, 10, 10, 11 |
|
| Week 4, n=3, 4, 2, 10, 10, 11 |
|
| Week 8, n=3, 4, 2, 10, 10, 10 |
|
| Week 12, n=3, 4, 2, 10, 10, 10 |
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| Week 16, n=2, 4, 2, 9, 10, 10 |
|
| Week 20, n=2, 4, 0, 7, 9, 9 |
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| Week 24, n=1, 3, 0, 5, 8, 9 |
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| Week 28, n=1, 3, 0, 4, 7, 8 |
|
| Week 32, n=1, 3, 0, 4, 7, 8 |
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| Week 36, n=1, 3, 0, 4, 7, 8 |
|
| Week 40, n=1, 3, 0, 4, 7, 8 |
|
| Week 44, n=1, 3, 0, 4, 7, 8 |
|
| Week 48, n=1, 3, 0, 4, 7, 8 |
|
| Week 4, n=2, 1, 2, 6, 3, 1 |
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| Week 8, n=2, 1, 2, 6, 3, 0 |
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| Week 12, n=2, 1, 2, 6, 3, 1 |
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| Week 16, n=1, 1, 2, 6, 3, 0 |
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| Week 20, n=2, 1, 2, 6, 3, 0 |
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| Week 24, n=1, 1, 2, 6, 3, 0 |
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| Week 4, n=3, 4, 2, 10, 10, 11 |
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| Week 4, n=3, 4, 2, 10, 10, 11 |
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| Week 8, n=3, 4, 2, 10, 10, 10 |
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| Week 12, n=3, 4, 2, 10, 10, 10 |
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| Week 16, n=2, 4, 2, 9, 10, 10 |
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| Week 20, n=2, 4, 0, 7, 9, 9 |
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| Week 24, n=1, 3, 0, 5, 8, 9 |
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| Week 28, n=1, 3, 0, 4, 7, 8 |
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| Week 32, n=1, 3, 0, 4, 7, 8 |
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| Week 36, n=1, 3, 0, 4, 7, 8 |
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| Week 40, n=1, 3, 0, 4, 7, 8 |
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| Week 44, n=1, 3, 0, 4, 7, 8 |
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| Week 48, n=1, 3, 0, 4, 7, 8 |
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| Week 4, n=2, 1, 2, 6, 3, 1 |
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| Week 8, n=2, 1, 2, 6, 3, 0 |
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| Week 12, n=2, 1, 2, 6, 3, 1 |
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| Week 16, n=1, 1, 2, 6, 3, 0 |
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| Week 20, n=2, 1, 2, 6, 3, 0 |
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| Week 24, n=1, 1, 2, 6, 3, 0 |
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| Week 4, n=0, 1, 0, 0, 1, 4 |
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| Week 4, n=0, 1, 0, 0, 1, 4 |
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| Week 8, n=0, 1, 0, 0, 1, 3 |
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| Week 12, n=0, 1, 0, 0, 1, 3 |
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| Week 16, n=0, 1, 0, 0, 1, 3 |
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| Week 20, n=0, 1, 0, 0, 1, 3 |
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| Week 24, n=0, 1, 0, 0, 1, 3 |
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| Week 28, n=0, 1, 0, 0, 1, 3 |
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| Week 32, n=0, 1, 0, 0, 1, 3 |
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| Week 36, n=0, 1, 0, 0, 1, 3 |
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| Week 40, n=0, 0, 0, 0, 1, 3 |
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| Week 44, n=0, 1, 0, 0, 1, 3 |
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| Week 48, n=0, 1, 0, 0, 1, 3 |
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| Week 4, n=0, 1, 0, 0, 1, 4 |
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| Week 4, n=0, 1, 0, 0, 1, 4 |
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| Week 8, n=0, 1, 0, 0, 1, 3 |
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| Week 12, n=0, 1, 0, 0, 1, 3 |
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| Week 16, n=0, 1, 0, 0, 1, 3 |
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| Week 20, n=0, 1, 0, 0, 1, 3 |
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| Week 24, n=0, 1, 0, 0, 1, 3 |
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| Week 28, n=0, 1, 0, 0, 1, 3 |
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| Week 32, n=0, 1, 0, 0, 1, 3 |
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| Week 36, n=0, 1, 0, 0, 1, 3 |
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| Week 40, n=0, 0, 0, 0, 1, 3 |
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| Week 44, n=0, 1, 0, 0, 1, 3 |
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| Week 48, n=0, 1, 0, 0, 1, 3 |
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