A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis

Trial Profile

A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis

Recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Oct 2017

At a glance

  • Drugs Povidone iodine/dexamethasone (Primary)
  • Indications Bacterial infections; Infectious conjunctivitis
  • Focus Therapeutic Use
  • Sponsors Shire
  • Most Recent Events

    • 02 May 2017 According to a Shire media release, the topline data is expected in Q2 2018.
    • 24 Apr 2017 According to a Shire media release, this trial is a part of the SYNCHRONIZE phase III clinical program for SHP640, which includes four multicenter, randomized, double-masked, placebo-controlled studies two for adenoviral conjunctivitis and two for bacterial conjunctivitis.
    • 24 Apr 2017 Status changed from not yet recruiting to recruiting, according to a Shire media release.
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