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A phase II, multicenter, randomized, double-masked, 4 parallel arms, controlled 6-month trial designed to evaluate the safety and efficacy of PAD ciclosporin (CsA 0.06% and 0.03%) ophthalmic dispersion administered once daily in combination with lubricant therapy and a 3-month post-treatment safety follow-up in moderate to severe dry eye patients

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Trial Profile

A phase II, multicenter, randomized, double-masked, 4 parallel arms, controlled 6-month trial designed to evaluate the safety and efficacy of PAD ciclosporin (CsA 0.06% and 0.03%) ophthalmic dispersion administered once daily in combination with lubricant therapy and a 3-month post-treatment safety follow-up in moderate to severe dry eye patients

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 17 Feb 2021

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At a glance

  • Drugs Ciclosporin (Primary) ; Hypromellose
  • Indications Dry eyes
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms NORTHERN LIGHTS
  • Sponsors MC2 Therapeutics

Most Recent Events

  • 06 Jun 2020 Results presented at the 21st Annual Congress of the European League Against Rheumatism
  • 22 Jun 2019 Primary endpoint (The primary efficacy variable is CFS response in the worse eye at Month 6, defined as at least a 2-grade improvement from baseline, as assessed with the modified Oxford scale) has been met as per Results presented at the 20th Annual Congress of the European League Against Rheumatism.
  • 15 Jun 2019 Results presented at the 20th Annual Congress of the European League Against Rheumatism

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