Last reviewed · How we verify
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.
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 41 |
| Start date | 2012-05 |
| Completion | 2014-06 |
Conditions
- Strabismus
Interventions
- GSK1358820
Primary outcomes
- 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.
Countries
Japan