Adenoviral ConjunctivitisPhase 2RUBYNCT03856645
OKG-0301 for the Treatment of Acute Adenoviral Conjunctivitis
A Phase 2 study testing OKG-0301 in people with Adenoviral Conjunctivitis, run by Okogen at 6 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenoviral Conjunctivitis
- What is being tested?
- OKG-0301
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 6 sitesAustralia
- Study dates
- 11 Feb 2019to 30 Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
- Have any uncontrolled (not on a stable regimen for the past 30 days) systemic disease or debilitating disease (e.g., cardiovascular disease, hypertension, diabetes, or cystic fibrosis) or taking medications known to impact the ocular surface and/or tear film.
- Have a planned overnight hospitalization during the period of the study.
- Have any uncontrolled (not on a stable regimen for the past 30 days) autoimmune disease or taking medications known to impact the ocular surface and/or tear film.
- Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device.
- Have a condition or a situation which, in the investigator's opinion, may put the patient at increased risk, confound study data, or interfere significantly with the patient's study participation.
- Be unlikely to follow study instructions or to complete all required study visits or has a condition or situation that in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Australia6 sites
The Royal Adelaide Hospital
Adelaide, South Australia, 5000
Albury Eye Clinic
Albury, New South Wales, 2640
Hobart Eye Surgeons
Hobart, Tasmania, 7000
The Royal Victorian Eye and Ear Hospital
Melbourne E., Victoria, 3002
Lions Eye Institute Day Surgery Centre
Nedlands, Western Australia, 6009
Sydney Eye Hospital
Sydney, New South Wales, 2000
About this study
Official title: 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
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
- Being tested
- OKG-0301
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OKG-0301Drug
OKG-0301 is an experimental ophthalmic antiviral and immunomodulatory therapeutic
| Study group | Role | What they receive |
|---|---|---|
| OKG-0301 0.012% w/v | Experimental | Not described Receives: Drug: OKG-0301 |
| OKG-0301 0.03% w/v | Experimental | Not described Receives: Drug: OKG-0301 |
| Vehicle Control | Placebo comparator | Not described Receives: Drug: OKG-0301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in viral titre levels in the study eye
PFU
Measured: Day 7
Secondary outcomes (6)
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: Day 4, 7 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start11 Feb 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoviral ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 219 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Okogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856645
- Sponsor's protocol ID
- OKO-210
- Acronym
- RUBY
- Status last verified
- Apr 2022
- First submitted
- 21 Feb 2019
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03856645
- Acronym / sponsor ID
- RUBY / OKO-210
- Conditions
- Adenoviral Conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 219 participants (estimated)
- Lead sponsor
- OkogenIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OKG-0301OKG-0301 is an experimental ophthalmic antiviral and immunomodulatory therapeutic | Drug | OKG-0301 0.012% w/v, OKG-0301 0.03% w/v, Vehicle Control |
Primary outcome
Mean change from baseline in viral titre levels in the study eye
Time frame: Day 7
PFU
6 secondary outcomes
Clinical Cure as Measured by the Absence of Bulbar Conjunctival Injection
Time frame: Day 4, 7 and 14
Clinical Cure as Measured by the Absence of Watery Conjunctival Discharge
Time frame: Day 4, 7 and 14
Adenoviral eradication (CC-IFA)
Time frame: Day 4, 7 and 14
Adenoviral eradication (PFU)
Time frame: Day 4, 7 and 14
Severity of subepithelial infiltrates
Time frame: Day 4, 7 and 14
The rate of cross-over infection
Time frame: Day 4, 7 and 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OKG-0301 in people with Adenoviral Conjunctivitis, run by Okogen at 6 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in viral titre levels in the study eye (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.