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What Type of Pivotal Study Design is Appropriate for an Investigational New Drug to Manage Chronic Angle Closure Glaucoma: Active Control or Placebo?

Abstract

In Asia, there is a need for agents to treat chronic angle closure glaucoma. This article highlights factors in determining whether to conduct an active or placebo control study and special circumstances that increase the complexity of this decision in clinical trials for chronic angle glaucoma trials. The authors advise the use of a placebo control design in pivotal clinical trials dealing with chronic angle closure glaucoma. Once a medication is approved for use in chronic angle closure glaucoma, subsequent pivotal trials of similar drugs can use an active control design.

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Author information

Correspondence to Yeong-Liang Lin MD.

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Lin, Y., Mau, B., Chern, H. et al. What Type of Pivotal Study Design is Appropriate for an Investigational New Drug to Manage Chronic Angle Closure Glaucoma: Active Control or Placebo?. Ther Innov Regul Sci 36, 499–500 (2002). https://doi.org/10.1177/009286150203600303

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Key Words

  • Angle closure glaucoma
  • Pivotal study
  • Active control
  • Placebo control