OKG-0301 for the Treatment of Acute Adenoviral Conjunctivitis

INTERVENTION: 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. CONDITION: Adenoviral Conjunctivitis;Infectious Conjunctivitis;Viral Conjunctivitis; ; Adenoviral Conjunctivitis ; Infectious Conjunctivitis ; Viral Conjunctivitis Eye ‐ Diseases / disorders of the eye Infection ‐ Other infectious diseases PRIMARY OUTCOME: Mean change from baseline in viral titre levels in the study eye at Visit 3. Viral titre levels are assessed by a quantitative viral plaque‐forming unit (PFU) assay used to measure the amount of infectious virus. This cell culture based technique is considered the gold standard for quantifying the "living" viral burden and will be determined from individual eye swabs.[Visit 3 (Day 7 +/‐ 1 day) ] INCLUSION CRITERIA: Each patient MUST: 1. Be willing and able to provide informed consent either written, or if the patient is not able to read, provide consent as stipulated by local laws and Human Research Ethics Committee (HREC) guidelines. 2. Be willing and able to follow all instructions and attend all study visits. 3. Have a clinical diagnosis of suspected acute adenoviral conjunctivitis in at least 1 eye and the presence of both of the following minimal clinical signs in that same eye: • Bulbar conjunctival redness: a minimum grade of ‘1’ on 0‐3 scale • Watery ocular discharge: a minimum grade of ‘1’ on a 0‐3 scale 4. Patient reported presence of signs and symptoms consistent with adenoviral conjunctivitis equal to or less than 3 days in same eye prior to Visit 1. 5. Have a positive AdenoPlus® test at Visit 1 in the same eye that meets the minimum 1+ grade for bulbar conjunctival redness and watery ocular discharge. 6. Be willing to SECONDARY OUTCOME: Adenoviral eradication assessed by cell culture immunofluorescence assay (CC‐IFA) determined from the eye swab taken at each visit.[Visits 2, 3 & 4 (Days 4 +/‐1d, 7 +/‐1d, & 14 +/‐1d, respectively) with visit 1 (Day 1) being the enrolment date and initiation of treatment] Global clinical cure of acute adenoviral conjunctivitis in the study eye as measured by the absence (score = 0) of the sum of the scores using the referenced scales for watery conjunctival discharge (graded on a scale of 0‐3 based on severity, developed specifically for this trial) and bulbar conjunctival redness (graded using the validated Ora Calibra Scale 16.2: Bulbar Conjunctival Redness Grading Scale) [Visits 2, 3 & 4 (Days 4 +/‐1d, 7 +/‐1d, & 14 +/‐1d, respectively) with visit 1 (Day 1) being the enrolment date and initiation of treatment] Presence and severity of subepithelial infiltrates assessed under slit lamp exam with Investigator grading on a semi‐quantitative scale.[Visits 2, 3 & 4 (Days 4 +/‐1d, 7 +/‐1d, & 14 +/‐1d, respectively) with visit 1 (Day 1) being the enrolment date and initiation of treatment] Safety measures will be assessed at each visit using Slit Lamp biomicroscopy (non‐dilated fundus examination), BSCVA, Adverse events (AEs), and tolerability by assessment of drop comfort in the fellow eye at Visit 1 by the patient upon instillation (self‐administered), at 5 minutes after instillation using visual analog scales.[Visits 2, 3 & 4 (Days 4 +/‐1d, 7 +/‐1d, & 14 +/‐1d, respectively) with visit 1 (Day 1) being the enrolment date and initiation of treatment] The rate of cross‐over infection to a patient’s fellow eye will be assessed for patients presenting at Visit 1 with only single eye infection based on clinical signs and symptoms. If fellow eye presents during visits 2, 3 or 4 based on clinical signs and symptoms, adenoviral presence will be confirmed using the AdenoPlus diagnostic.[Visits 2, 3 & 4 (Days 4 +/‐1d, 7 +/‐1d, & 14 +/‐1d, respectively) with visit 1 (Day 1) being the enrolment date and initiation of treatment]