StrabismusPhase 3NCT01584843
Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Strabismus
A Phase 3 study testing GSK1358820 in people with Strabismus, run by GlaxoSmithKline at 13 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Strabismus
- What is being tested?
- GSK1358820
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 13 sitesJapan
- Study dates
- May 2012to Jun 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- <At the start of screening period>
- Paralytic or concomitant strabismus. Subjects with paralytic strabismus will be eligible for inclusion only if paralysis has persisted for at least 3 months and strabismus has been developed at one eye
- Horizontal deviations (esotropia or exotropia)
- Strabismus with the (absolute) strabismus angles at both distance and near of primary position >-10 PD and <50 PD
- Age>-12 years at the time of giving informed consent
- The subject has to be capable of giving written informed consent of their own will. For subjects aged less than 20 years, the subject and his/her legally acceptable representative (person in parental authority or guardian) have to give written informed consent
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- Either sex. Males have to agree to practice contraception during the study period. Females of child-bearing potential will be eligible for inclusion in this study. However, they have to have negative pregnancy test both at the screening visit and just before initial injection and agree to practice reliable methods of contraception
- QTc <450 msec; for patients with Bundle Branch Block, QTc <480 msec based on average QTc value of triplicate ECGs <At the start of treatment period >
- Strabismus with the (absolute) strabismus angles at both distance and near of primary position >-10 PD and <50 PD
- ALT at the screening visit <2 x ULN and alkaline phosphatase and bilirubin <-1.5 x ULN
Who cannot join
- <At the start of screening period>
- Secondary strabismus caused by prior surgical recession of the antagonist in past surgical treatment of strabismus
- Strabismus due to abnormal innervations
- Strabismus with thyroid-associated ophthalmopathy
- Strabismus with strong motor limitation of extraocular muscles
- Mechanical limitations of ocular movement due to periorbital disease or due to past surgical treatment other than strabismus
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- Blepharoptosis
- Conjunctival pathology
- Systemic neuromuscular junction dysfunction
- Systemic neuromuscular disease
- Past treatment with botulinum toxin
- Planned injections of botulinum toxin for other indication(s) or for cosmetic purpose during the study period
- Known hypersensitivity to any of the drugs to be used in the study or history of allergy
- Treatment with antibiotics with neuromuscular junction inhibitory action such as aminoglycosides, polypeptides, tetracyclines and lincomycins, except those contained in topical antibacterial formulations
- Treatment with muscle relaxants or drugs with muscle relaxant action
- Chronic respiratory disorder
- Severe muscle weakness or atrophy
- Angle-closure glaucoma or its predisposing factors
- Severe cardiac, hepatic or renal impairment. The severity refers to Grade 3 according to "the Classification of the Severity of Adverse Experiences" (MHLW PAB/SD Notification No. 80, dated 29 June 1992).
- Surgical operation or hospitalization to be needed during the study period
- Female subjects who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study period
- Participation in another clinical study within 6 months prior to enrollment in this study or planned participation in another clinical study after enrollment in this study
- Psychiatric disorder or impairment of intellectual function that may affect the subject's ability to give informed consent or to comply with the trial procedures
- History of alcohol dependence or drug abuse
- Subjects whom the investigator (or sub-investigator) considers ineligible for the study
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Japan13 sites
GSK Investigational Site
Aichi, 494-0001
GSK Investigational Site
Fukuoka, 812-0011
GSK Investigational Site
Hyōgo, 663-8501
GSK Investigational Site
Kagoshima, 890-0046
GSK Investigational Site
Kanagawa, 252-0375
GSK Investigational Site
Miyazaki, 880-0035
GSK Investigational Site
Miyazaki, 885-0051
GSK Investigational Site
Osaka, 535-0021
GSK Investigational Site
Osaka, 569-8686
GSK Investigational Site
Shizuoka, 431-3192
GSK Investigational Site
Tokyo, 101-0062
GSK Investigational Site
Tokyo, 134-0088
GSK Investigational Site
Yamaguchi, 750-0061
About this study
Official title: A Multicenter, Randomized, Evaluator-masked, Parallel-group, Non-treatment-controlled Study Followed by an Open-label Study to Evaluate Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Strabismus
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.
Read the detailed description
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.
- Conditions
- Strabismus
- Being tested
- GSK1358820
- Keywords
- Neuromuscular Agents, Strabismus, Botulinum Toxin Type A
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1358820Drug
Also called Botulinum Toxin Type A
IM injection of Botulinum Toxin Type A
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: GSK1358820 |
| GSK1358820 2.5 U (10-20 PD) | Active comparator | Receive 2.5 U of GSK1358820 on Week 0 Receives: Drug: GSK1358820 |
| 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 Receives: Drug: GSK1358820 |
| GSK1358820 5.0 U (20-50 PD) | Active comparator | Receive 5.0 U of GSK1358820 on Week 0 Receives: Drug: GSK1358820 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 4 of the FTP
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrabismusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584843
- Sponsor's protocol ID
- 116246
- Status last verified
- Mar 2015
- First submitted
- 23 Apr 2012
- Last updated
- 24 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Evaluator-masked, Parallel-group, Non-treatment-controlled Study Followed by an Open-label Study to Evaluate Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Strabismus
- ClinicalTrials.gov ID
- NCT01584843
- Acronym / sponsor ID
- 116246
- Conditions
- Strabismus
- Keywords
- Neuromuscular Agents, Strabismus, Botulinum Toxin Type A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Apr 2012 (estimated)
- Results
- Posted 1 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Non-treatment (10-20 PD) | No intervention | –Receive no treatment on Week 0 |
| GSK1358820 1.25 U (10-20 PD) | Active comparator | Drug: GSK1358820Receive 1.25 U of GSK1358820 on Week 0 |
| GSK1358820 2.5 U (10-20 PD) | Active comparator | Drug: GSK1358820Receive 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 | Drug: GSK1358820Receive 2.5 U of GSK1358820 on Week 0 |
| GSK1358820 5.0 U (20-50 PD) | Active comparator | Drug: GSK1358820Receive 5.0 U of GSK1358820 on Week 0 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- <At the start of screening period>
- Paralytic or concomitant strabismus. Subjects with paralytic strabismus will be eligible for inclusion only if paralysis has persisted for at least 3 months and strabismus has been developed at one eye
- Horizontal deviations (esotropia or exotropia)
- Strabismus with the (absolute) strabismus angles at both distance and near of primary position >-10 PD and <50 PD
- Age>-12 years at the time of giving informed consent
Key exclusion criteria (25 listed)
- <At the start of screening period>
- Secondary strabismus caused by prior surgical recession of the antagonist in past surgical treatment of strabismus
- Strabismus due to abnormal innervations
- Strabismus with thyroid-associated ophthalmopathy
- Strabismus with strong motor limitation of extraocular muscles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK1358820Also: Botulinum Toxin Type AIM injection of Botulinum Toxin Type A | Drug | GSK1358820 1.25 U (10-20 PD), GSK1358820 2.5 U (10-20 PD), GSK1358820 2.5 U (20-50 PD), GSK1358820 5.0 U (20-50 PD) |
Primary outcome
Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC)
Time frame: 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.
16 secondary outcomes
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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)
Duration of Effect
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GSK1358820 in people with Strabismus, run by GlaxoSmithKline at 13 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC) (time frame: Baseline and Week 4 of the FTP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2015.