Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001724167p
Ethics application status
Submitted, not yet approved
Date submitted
27/11/2019
Date registered
6/12/2019
Date last updated
5/02/2020
Date data sharing statement initially provided
6/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Safety and Efficacy of CMB-012 in Subjects with Chemical Burns of the
Cornea and/or Persistent Corneal Epithelial Defects (PCED)
Scientific title
A Phase 1b, Open-Label, Single-Arm Study to Evaluate the Safety
and Efficacy of CMB-012 in Subjects with Chemical Burns of the
Cornea and/or Persistent Corneal Epithelial Defects (PCED)
Secondary ID [1] 299922 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent Corneal Epithelial Defect 315350 0
Chemical Burn 315351 0
Condition category
Condition code
Eye 313657 313657 0 0
Diseases / disorders of the eye
Injuries and Accidents 313780 313780 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CMB-012 (6 ug/mL) administered twice daily for two weeks, unilaterally (affected eye only). Topical ocular administration: form of each administration is 30 uL eye drop.

Participants are provided diary card to record dates and times of self-administration; diary cards are collected at each weekly office visit to monitor adherence to intervention.
Intervention code [1] 316194 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322085 0
(Safety outcome)
Ocular tolerability/pain by visual analogue scale score.
Timepoint [1] 322085 0
1 week, 2 weeks (primary timepoint) & 1 month after intervention commencement.
2 weeks and 12 weeks after end of intervention.
Primary outcome [2] 322086 0
(Safety outcome)
Changes from baseline in vital signs (blood pressure, pulse and temperature)
Composite endpoint.

Blood pressure and pulse will be measured by digital sphygmomanometer. Temperature will be measured by thermometer.
Timepoint [2] 322086 0
1 week, 2 weeks (primary timepoint) & 1 month after intervention commencement.
2 weeks and 12 weeks after end of intervention.
Primary outcome [3] 322087 0
(Safety outcome)
Change from baseline in clinical ocular examination: intraocular pressure measured using Tono-Pen.
Timepoint [3] 322087 0
1 week, 2 weeks (primary timepoint) & 1 month after intervention commencement.
2 weeks and 12 weeks after end of intervention.
Secondary outcome [1] 377286 0
(Safety outcome)
Primary outcome (4) Change from baseline in clinical ocular examination: dilated fundus ophthalmoscopy assessed by ophthalmologist.
Timepoint [1] 377286 0
1 week, 2 weeks (primary timepoint) & 1 month after intervention commencement.
2 weeks and 12 weeks after end of intervention.
Secondary outcome [2] 377302 0
(Safety outcome)
Primary outcome (5) Change from baseline in clinical ocular examination: slit lamp assessment by ophthalmologist (or trained nurse or orthoptist).
Timepoint [2] 377302 0
1 week, 2 weeks (primary timepoint) & 1 month after intervention commencement.
2 weeks and 12 weeks after end of intervention.
Secondary outcome [3] 377303 0
Primary outcome (6) Change from baseline in clinical ocular examination: best corrected distance visual acuity assessed using Snellen Eye Charts.
Timepoint [3] 377303 0
1 week, 2 weeks (primary timepoint) & 1 month after intervention commencement.
2 weeks and 12 weeks after end of intervention.
Secondary outcome [4] 377640 0
Change in lesion size from baseline using slit lamp examination.
Timepoint [4] 377640 0
1 week, 2 weeks & 1 month after intervention commencement.
2 weeks and 12 weeks after end of intervention.
Secondary outcome [5] 377641 0
Change in corneal opacity from baseline using clinician questionnaire (designed specifically for this study).
Timepoint [5] 377641 0
1 week, 2 weeks & 1 month after intervention commencement.
2 weeks and 12 weeks after end of intervention.
Secondary outcome [6] 377642 0
Change in corneal neovascularization from baseline using clinician questionnaire (designed specifically for this study).
Timepoint [6] 377642 0
1 week, 2 weeks & 1 month after intervention commencement.
2 weeks and 12 weeks after end of intervention.
Secondary outcome [7] 377643 0
(Safety outcome)
Primary outcome (7) Incidence rates, frequency, severity, and duration of adverse events by relationship to study intervention and those that led to discontinuation of the study intervention.


Examples of possible adverse events include:

-ocular surface inflammation; corneal deposits; foreign body sensation; ocular hyperemia; ocular inflammation and tearing; infection assessed using slit lamp

-sudden decrease in vision assessed using Snellen Eye Charts

-increase in intraocular pressure assessed using Tono-Pen
Timepoint [7] 377643 0
1 week, 2 weeks (primary timepoint) & 1 month after intervention commencement.
2 weeks and 12 weeks after end of intervention.

Eligibility
Key inclusion criteria
Participants with persistent corneal epithelial defect (PCED) of at least 10 days refractory to one or more conventional non-surgical treatments in study eye (e.g., preservative-free artificial tears, gels or ointments; therapeutic contact lenses).

Participants with corneal burns occurring within 24 hours prior to commencement of intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with severe eyelid abnormalities contributory to the persistence of the persistent corneal epithelial defect (PCED).

Any active ocular infection (bacterial, viral, fungal or protozoal) based on corneal and bacterial cultures taken during the screening period.

More than one distinct PCED in the study eye.

Evidence of corneal ulceration involving the posterior third of the corneal stroma, corneal melting or perforation in the study eye

Presence or history of any ocular or systemic disorder or condition that may hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the Investigator to be incompatible with the study visit schedule or conduct (e.g., progressive or degenerative corneal or retinal conditions, uveitis, optic neuritis, poorly controlled diabetes, autoimmune disease, systemic infection, neoplastic diseases).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Sponsor decision to allocate resources to ongoing clinical study at another institution
Date of first participant enrolment
Anticipated
24/02/2020
Actual
Date of last participant enrolment
Anticipated
6/04/2020
Actual
Date of last data collection
Anticipated
30/09/2020
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304384 0
Commercial sector/Industry
Name [1] 304384 0
Combangio, Inc.
Country [1] 304384 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Combangio, Inc.
Address
1490 O'Brien Drive
Suite C
Menlo Park, CA 94025
Country
United States of America
Secondary sponsor category [1] 304646 0
None
Name [1] 304646 0
Address [1] 304646 0
Country [1] 304646 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304822 0
Bellberry Limited
Ethics committee address [1] 304822 0
123 Glen Osmond Road, Eastwood SA 5063
Ethics committee country [1] 304822 0
Australia
Date submitted for ethics approval [1] 304822 0
13/11/2019
Approval date [1] 304822 0
Ethics approval number [1] 304822 0

Summary
Brief summary
This Phase 1b study is designed to assess the safety and tolerability of repeated topical ocular administration of CMB-012, 2 times per day , in participants with chemical burns of the cornea and/or persistent corneal epithelial defect, to allow a preliminary assessment of a safe and efficacious dose to be studied in further clinical studies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98318 0
Prof Stephanie Watson
Address 98318 0
The University of Sydney
Level 1 South Block
Sydney Hospital
8 Macquarie Street
Sydney NSW 2000
Country 98318 0
Australia
Phone 98318 0
+61 2 9389 0666
Fax 98318 0
Email 98318 0
[email protected]
Contact person for public queries
Name 98319 0
Mr Darius Kharabi
Address 98319 0
Combangio, Inc.
1490 O'Brien Drive, Suite C
Menlo Park CA 94025
Country 98319 0
United States of America
Phone 98319 0
+1 650 539 0715
Fax 98319 0
Email 98319 0
[email protected]
Contact person for scientific queries
Name 98320 0
Mr Darius Kharabi
Address 98320 0
Combangio, Inc.
1490 O'Brien Drive, Suite C
Menlo Park CA 94025
Country 98320 0
United States of America
Phone 98320 0
+1 650 539 0715
Fax 98320 0
Email 98320 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.