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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
219
OKG-0301 is an experimental ophthalmic antiviral and immunomodulatory therapeutic
Albury Eye Clinic
Albury, New South Wales, Australia
Sydney Eye Hospital
Sydney, New South Wales, Australia
The Royal Adelaide Hospital
Adelaide, South Australia, Australia
Hobart Eye Surgeons
Hobart, Tasmania, Australia
The Royal Victorian Eye and Ear Hospital
Melbourne E., Victoria, Australia
Lions Eye Institute Day Surgery Centre
Nedlands, Western Australia, Australia
Mean change from baseline in viral titre levels in the study eye
PFU
Time frame: Day 7
Clinical Cure as Measured by the Absence of Bulbar Conjunctival Injection
Clinical cure of acute adenoviral conjunctivitis as measured by the absence (score = 0) of bulbar conjunctival redness (graded using the validated Ora Calibra Scale 16.2: Bulbar Conjunctival Redness Grading Scale)
Time frame: Day 4, 7 and 14
Clinical Cure as Measured by the Absence of Watery Conjunctival Discharge
Clinical cure of acute adenoviral conjunctivitis as measured by the absence (score = 0) of watery conjunctival discharge (graded on a scale of 0-3 based on severity, developed specifically for this trial)
Time frame: Day 4, 7 and 14
Adenoviral eradication (CC-IFA)
Adenoviral eradication is defined as negative CC-IFA. CC-IFA will be conducted using conjunctival swab samples collected at each visit to determine the presence or absence of adenovirus.
Time frame: Day 4, 7 and 14
Adenoviral eradication (PFU)
Adenoviral eradication is defined as zero plaques in cultures of ocular samples. PFU will be conducted using conjunctival swab samples collected at each visit to determine the presence or absence of adenovirus.
Time frame: Day 4, 7 and 14
Severity of subepithelial infiltrates
Evaluation of SEIs in study eye, assessed under slit lamp exam with Investigator grading on a 0-3 semi-quantitative scale (developed specifically for this study).
Time frame: Day 4, 7 and 14
The rate of cross-over infection
Clinical signs in contra-lateral eye that initially presented with no signs or symptoms of adenoviral conjunctivitis
Time frame: Day 4, 7 and 14
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