RecruitingPhase 2ACTRN12619000177156

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 (RUBY)

Sponsor

Okogen Pty Ltd

Enrollment

219 participants

Start Date

Feb 11, 2019

Study Type

Interventional

Conditions

Infectious Conjunctivitis Viral Conjunctivitis

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Adenoviral conjunctivitis — better known as 'viral pink eye' — is a highly contagious eye infection caused by adenovirus. It spreads easily, causes significant discomfort (redness, watery discharge, irritation), and can sometimes lead to lasting complications like cloudy patches on the cornea (subepithelial infiltrates) that affect vision. Currently, there is no proven antiviral treatment for this condition. OKG-0301 is a new experimental eye drop solution containing a protein called ribonuclease that has broad antiviral activity against adenovirus. This Phase 2 study tests whether OKG-0301 eye drops are safe and more effective than a vehicle (inactive) eye drop in reducing the amount of virus in the eye and clearing the infection faster. The study is conducted entirely in Australia. You may be eligible if you are 18 or older, have signs and symptoms of acute adenoviral conjunctivitis that started within the last 3 days, have at least mild redness and watery discharge in one eye, and test positive for adenovirus on a rapid test. You are not eligible if you have other active eye infections or inflammation, a history of dry eye or recurrent corneal erosion, are pregnant or breastfeeding, or have used antiviral or steroid eye drops recently.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OKG-0301 (either 0.012% or 0.03%), a preserved ophthalmic solution containing Ranpirnase, will be instilled as a topical eye drop, 4 times per day for 5 days. Patients will be randomized in accordance with a predefined block randomization schedule based, in part, on site of presentation. Patients will also be required to complete a diary to document adherence to dosing schedule. This diary will be reviewed with the Investigators at each visit.