OKG-0301 for the Treatment of Acute Adenoviral Conjunctivitis
Status:
Active, not recruiting
Trial end date:
2021-06-30
Target enrollment:
Participant gender:
Summary
Acute adenoviral conjunctivitis is a highly contagious, widespread endemic disease associated
with frequent outbreaks, significant patient discomfort, lost productivity, and in some cases
permanent visual compromise from long-term immune mediated sequelae. OKG-0301 is a novel
ophthalmic solution with a potent ribonuclease that has broad-spectrum antiviral properties
relevant for the treatment of acute adenoviral conjunctivitis. This randomized, double
masked, multi-center Phase 2 study is being conducted entirely within Australia and is
designed to support the safety and efficacy of OKG-0301 for the treatment of acute adenoviral
conjunctivitis. The study intends to show superiority of OKG-0301 Ophthalmic Solution
compared to vehicle for the primary efficacy endpoint of mean change from baseline in viral
titre in patients with acute adenoviral conjunctivitis. Secondary efficacy endpoints
including adenoviral eradication, clinical cure of acute adenoviral conjunctivitis,
subepithelial infiltrates, other clinical signs and symptoms, and rate of cross-over
infection to the other eye will also be assessed. Safety will also be evaluated.