Trial Profile

A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 18 Nov 2021

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At a glance

Drugs Ciclosporin (Primary)
Indications Dry eyes; Keratoconjunctivitis sicca
Focus Registrational; Therapeutic Use
Acronyms Emerald
Sponsors Ocular Technologies; Sun Pharma Global FZE; Sun Pharmaceutical Industries

Most Recent Events

14 Oct 2019 Results published in the Sun Pharmaceutical Industries Media Release
16 Aug 2018 According to a Sun Pharmaceutical media release, the US FDA has approved OTX-101 (cyclosporine A, ophthalmic solution) 0.09% to treat dry eye disease.
27 Dec 2017 According to a Sun Pharmaceutical media release, the US FDA has accepted a New Drug Application (NDA) for OTX-101 (cyclosporine A, ophthalmic solution) 0.09%.

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