Trial · NCT01584843
Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Strabismus
NCT01584843, Phase 3, Completed, GlaxoSmithKline; results first posted 2014-08-01
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Strabismus. Trials, record NCT01584843. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01584843
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Strabismus
- NCT number
- NCT01584843
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 41 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Strabismus
- Interventions
- GSK1358820
- First posted
- 2012-04-25
- Last updated
- 2015-07-24
- Results first posted
- 2014-08-01
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC) | Baseline and Week 4 of the FTP | 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. |
| 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) | Baseline and Week 1 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. Change from Baseline was calculated as the value at Week 1minus the value at Baseline. |
| 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 | Baseline and 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. |
| 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) | Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52) | 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. |
| Secondary | Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP | 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. |
| 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 | 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). |
| Secondary | Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP | Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52) | 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. |
| 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 | Baseline and 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 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. |
| 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 | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 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 |
| 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 | Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52) | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC) | Baseline and Week 4 of the FTP | 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. | prism dioptre | MEAN |
| 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) | Baseline and Week 1 of the FTP | FAS1 Population | prism dioptre | MEAN |
| 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 | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP | FAS1 Population | prism dioptre | MEAN |
| 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) | Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52) | 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 | prism dioptre | MEAN |
| SECONDARY | Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP | Weeks 1 and 4 of the FTP | FAS1 Population | prism dioptre | MEAN |
| 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 | Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP | FAS1 Population | prism dioptre | MEAN |
| SECONDARY | Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP | Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52) | FAS2 population. | prism dioptre | MEAN |
| 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 | Baseline and Weeks 1 and 4 of the FTP | FAS1 Population | Percent change in prism dioptre | MEAN |
| 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 | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 of the FTP | FAS1 Population | Percent change in prism dioptre | MEAN |
| 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 | Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52) | FAS2 Population | Percent change in prism dioptre | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group582
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC) | BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 | 2.33 | Standard Deviation 6.602 | prism dioptre | |
| Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC) | BSA >=10 PD and <20 PD: GSK1358820 1.25 U | -7.50 | Standard Deviation 7.141 | prism dioptre | |
| Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC) | BSA >=10 PD and <20 PD: GSK1358820 2.5 U | -3.75 | Standard Deviation 2.475 | prism dioptre | |
| Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC) | SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 | -0.55 | Standard Deviation 2.291 | prism dioptre | |
| Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC) | BSA >=20 PD and <50 PD: GSK1358820 2.5 U | -13.40 | Standard Deviation 15.105 | prism dioptre | |
| Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC) | BSA >=20 PD and <50 PD: GSK1358820 5.0 U | -17.27 | Standard Deviation 15.476 | prism dioptre | |
| 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) | BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 | 1.50 | Standard Deviation 1.323 | prism dioptre | |
| 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) | BSA >=10 PD and <20 PD: GSK1358820 1.25 U | -5.75 | Standard Deviation 8.180 | prism dioptre | |
| 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) | BSA >=10 PD and <20 PD: GSK1358820 2.5 U | 8.83 | Standard Deviation 19.902 | prism dioptre | |
| 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) | BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 | -1.70 | Standard Deviation 3.285 | prism dioptre |
1 to 10 of 582Source ClinicalTrials.gov
See all 582 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Treatment Period | STARTED | BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 | 3 | |
| First Treatment Period | STARTED | BSA >=10 PD and <20 PD: GSK1358820 1.25 U | 4 | |
| First Treatment Period | STARTED | BSA >=10 PD and <20 PD: GSK1358820 2.5 U | 3 | |
| First Treatment Period | STARTED | BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 | 10 | |
| First Treatment Period | STARTED | BSA >=20 PD and <50 PD: GSK1358820 2.5 U | 10 | |
| First Treatment Period | STARTED | BSA >=20 PD and <50 PD: GSK1358820 5.0 U | 11 | |
| First Treatment Period | COMPLETED | BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820 | 3 | |
| First Treatment Period | COMPLETED | BSA >=10 PD and <20 PD: GSK1358820 1.25 U | 4 | |
| First Treatment Period | COMPLETED | BSA >=10 PD and <20 PD: GSK1358820 2.5 U | 2 | |
| First Treatment Period | COMPLETED | BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820 | 10 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events160
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Eyelid ptosis | Eye disorders | Non-treatment | 0 | 13 | |
| other | Eyelid ptosis | Eye disorders | Non-treatment, Then GSK1358820 | 3 | 13 | |
| other | Eyelid ptosis | Eye disorders | GSK1358820 1.25 U | 0 | 4 | |
| other | Eyelid ptosis | Eye disorders | GSK1358820 2.5 U | 2 | 13 | |
| other | Eyelid ptosis | Eye disorders | GSK1358820 5.0 U | 2 | 11 | |
| other | Conjunctival haemorrhage | Eye disorders | Non-treatment | 0 | 13 | |
| other | Conjunctival haemorrhage | Eye disorders | Non-treatment, Then GSK1358820 | 0 | 13 | |
| other | Conjunctival haemorrhage | Eye disorders | GSK1358820 1.25 U | 0 | 4 | |
| other | Conjunctival haemorrhage | Eye disorders | GSK1358820 2.5 U | 1 | 13 | |
| other | Conjunctival haemorrhage | Eye disorders | GSK1358820 5.0 U | 1 | 11 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Non-treatment | ||
| Total, all-cause mortality | Non-treatment, Then GSK1358820 | ||
| Total, all-cause mortality | GSK1358820 1.25 U | ||
| Total, all-cause mortality | GSK1358820 2.5 U | ||
| Total, all-cause mortality | GSK1358820 5.0 U | ||
| Total, other adverse events | Non-treatment | 1 | 13 |
| Total, other adverse events | Non-treatment, Then GSK1358820 | 8 | 13 |
| Total, other adverse events | GSK1358820 1.25 U | 1 | 4 |
| Total, other adverse events | GSK1358820 2.5 U | 6 | 13 |
| Total, other adverse events | GSK1358820 5.0 U | 6 | 11 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01584843
GET https://conductscience.org/api/trials/v1/NCT01584843/results?page=2