OKG-0301 for the Treatment of Acute Adenoviral Conjunctivitis

NCT03856645 | Unknown Phase 2 FDA Drug

• 1 other identifier: OKO-210
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in viral titre levels in the study eye

  PFU

  Day 7

Secondary Outcomes (6)

• Clinical Cure as Measured by the Absence of Bulbar Conjunctival Injection

  Day 4, 7 and 14

• Clinical Cure as Measured by the Absence of Watery Conjunctival Discharge

  Day 4, 7 and 14

• Adenoviral eradication (CC-IFA)

  Day 4, 7 and 14

• Adenoviral eradication (PFU)

  Day 4, 7 and 14

• Severity of subepithelial infiltrates

  Day 4, 7 and 14

Study Arms (3)

OKG-0301 0.012% w/v

EXPERIMENTAL

Drug: OKG-0301

OKG-0301 0.03% w/v

EXPERIMENTAL

Drug: OKG-0301

Vehicle Control

PLACEBO COMPARATOR

Drug: OKG-0301

Interventions

OKG-0301 DRUG

OKG-0301 is an experimental ophthalmic antiviral and immunomodulatory therapeutic

OKG-0301 0.012% w/v; OKG-0301 0.03% w/v; Vehicle Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each patient MUST:
• 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:
• 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
• 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.

You may not qualify if:

• Each patient MUST NOT:
• Have known sensitivity or poor tolerance to any component of the study medications or diagnostics.
• 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.
• Have presence of any other clinically significant findings during the slit lamp exam that may interfere with study parameters or otherwise confound the data as determined by the investigator
• Have any clinically significant retinal or optic nerve findings (as observed in the non-dilated fundus exam) or prior diagnoses in either eye that may interfere with study parameters or otherwise confound the data as determined by the investigator).
• Have used any topical ocular or systemic anti-viral or topical ocular or systemic corticosteroid within 7 days of enrollment and do not plan to start any topical ocular or systemic anti-viral during study duration. Inhaled, intranasal, and topical dermatologic steroids (except on the face) are allowed during the study.
• Initiate or continue the use of warm or cold compresses for the duration of the trial.
• Have used any topical ophthalmic solutions, including tear substitutes and diagnostics, within 2 hours of Visit 1 and be unable to discontinue all topical ophthalmic solutions (including diagnostics, except as required by this protocol and antibiotics) for the duration of the study. In addition, if the patient has used an artificial tear or other topical ophthalmic formulated in a hydrogel within the past 72 hours.
• Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test.

Sponsors & Collaborators

• Okogen: lead

Study Sites (6)

Albury Eye Clinic

Albury, New South Wales, 2640, Australia

Location

Sydney Eye Hospital

Sydney, New South Wales, 2000, Australia

Location

The Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Hobart Eye Surgeons

Hobart, Tasmania, 7000, Australia

Location

The Royal Victorian Eye and Ear Hospital

Melbourne E., Victoria, 3002, Australia

Location

Lions Eye Institute Day Surgery Centre

Nedlands, Western Australia, 6009, Australia

Location

Related Links

• Registration number: ACTRN12619000177156

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 27, 2019
• Study Start: February 11, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 21, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6)