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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03856645




Registration number
NCT03856645
Ethics application status
Date submitted
21/02/2019
Date registered
27/02/2019
Date last updated
26/03/2019

Titles & IDs
Public title
OKG-0301 for the Treatment of Acute Adenoviral Conjunctivitis
Scientific 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
Secondary ID [1] 0 0
OKO-210
Universal Trial Number (UTN)
Trial acronym
RUBY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenoviral Conjunctivitis 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OKG-0301

Experimental: OKG-0301 0.012% w/v -

Experimental: OKG-0301 0.03% w/v -

Placebo Comparator: Vehicle Control -


Treatment: Drugs: OKG-0301
OKG-0301 is an experimental ophthalmic antiviral and immunomodulatory therapeutic

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean change from baseline in viral titre levels in the study eye - PFU
Timepoint [1] 0 0
Day 7
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
Day 4, 7 and 14
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
Day 4, 7 and 14
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Day 4, 7 and 14
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Day 4, 7 and 14
Secondary outcome [5] 0 0
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).
Timepoint [5] 0 0
Day 4, 7 and 14
Secondary outcome [6] 0 0
The rate of cross-over infection - Clinical signs in contra-lateral eye that initially presented with no signs or symptoms of adenoviral conjunctivitis
Timepoint [6] 0 0
Day 4, 7 and 14

Eligibility
Key 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 discontinue contact lens wear for the duration of the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Each patient MUST NOT:

1. Have known sensitivity or poor tolerance to any component of the study medications or
diagnostics.

2. Have a history of ocular surgical intervention or trauma within 12 weeks prior to
Visit 1 or planned for the period of the study.

3. Have presence of any active ocular inflammation (e.g., uveitis, allergic
conjunctivitis, ocular rosacea, or iritis), other than acute adenoviral
conjunctivitis.

4. 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).

5. Have the presence of corneal subepithelial infiltrates at baseline.

6. Have a history of recurrent corneal erosion syndrome, ulcerative keratitis or dry eye,
including meibomian gland dysfunction and other ocular surface diseases.

7. Have presence of blepharitis, lid abnormality, significant inflammation of the lid
margin, or ptosis.

8. Have lacrimal duct obstruction in either eye.

9. 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

10. 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).

11. 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.

12. Initiate or continue the use of warm or cold compresses for the duration of the trial.

13. 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.

14. Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a
positive pregnancy test.

15. 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.

16. Have a planned overnight hospitalization during the period of the study.

17. 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.

18. Have prior (within 30 days of beginning study treatment) or anticipated concurrent use
of an investigational drug or device.

19. 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.

20. 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Albury Eye Clinic - Albury
Recruitment hospital [2] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [3] 0 0
University New South Wales - Sydney
Recruitment hospital [4] 0 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Hobart Eye Surgeons - Hobart
Recruitment hospital [6] 0 0
The Royal Victorian Eye and Ear Hospital - Melbourne E.
Recruitment hospital [7] 0 0
Lions Eye Institute Day Surgery Centre - Nedlands
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2052 - Sydney
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment postcode(s) [6] 0 0
3002 - Melbourne E.
Recruitment postcode(s) [7] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Okogen
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03856645
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Eric Daniels, MD
Address 0 0
Country 0 0
Phone 0 0
760-253-8402
Fax 0 0
Email 0 0
edaniels@okogen.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03856645