NCT03856645

OKG-0301 for the Treatment of Acute Adenoviral Conjunctivitis

A Phase 2, Multi-centeR, Randomized, DoUBle-Masked, Placebo-Controlled StudY to Evaluate the Clinical Safety and Efficacy of OKG-0301 in the Treatment of Acute Adenoviral Conjunctivitis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 219 (estimated)
• Sponsor: Okogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenoviral Conjunctivitis

Interventions

Type	Name	Description
DRUG	OKG-0301	OKG-0301 is an experimental ophthalmic antiviral and immunomodulatory therapeutic

Timeline

• Start date: 2019-02-11
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2019-02-27
• Last updated: 2022-04-21

Locations

6 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study