OKG-0301 for the Treatment of Acute Adenoviral Conjunctivitis (NCT03856645) | Clinical Trial Compass
UnknownPhase 2
OKG-0301 for the Treatment of Acute Adenoviral Conjunctivitis
Australia219 participantsStarted 2019-02-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Be willing and able to follow all instructions and attend all study visits.
✓. 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:
✓. 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.
✓. 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.
✓. Be willing to discontinue contact lens wear for the duration of the study.
Exclusion criteria
✕. Have known sensitivity or poor tolerance to any component of the study medications or diagnostics.
✕
What they're measuring
1
Mean change from baseline in viral titre levels in the study eye
. Have a history of ocular surgical intervention or trauma within 12 weeks prior to Visit 1 or planned for the period of the study.
✕. Have presence of any active ocular inflammation (e.g., uveitis, allergic conjunctivitis, ocular rosacea, or iritis), other than acute adenoviral conjunctivitis.
✕. Have clinical signs or presence of an ocular infection other than acute adenoviral conjunctivitis (e.g., bacterial, fungal or other ocular viral infection, such as herpes).
✕. Have the presence of corneal subepithelial infiltrates at baseline.
✕. Have a history of recurrent corneal erosion syndrome, ulcerative keratitis or dry eye, including meibomian gland dysfunction and other ocular surface diseases.
✕. Have presence of blepharitis, lid abnormality, significant inflammation of the lid margin, or ptosis.
✕. Have lacrimal duct obstruction in either eye.