Evaluation of the Safety and Efficacy of CMB-012 in Subjects with Chemical Burns of theCornea and/or Persistent Corneal Epithelial Defects (PCED)
- Conditions
- Persistent Corneal Epithelial DefectChemical BurnEye - Diseases / disorders of the eyeInjuries and Accidents - Burns
- Registration Number
- ACTRN12619001724167
- Lead Sponsor
- Combangio, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 6
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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (Safety outcome)<br>Ocular tolerability/pain by visual analogue scale score.[1 week, 2 weeks (primary timepoint) & 1 month after intervention commencement. <br>2 weeks and 12 weeks after end of intervention.];(Safety outcome)<br>Changes from baseline in vital signs (blood pressure, pulse and temperature)<br>Composite endpoint.<br><br>Blood pressure and pulse will be measured by digital sphygmomanometer. Temperature will be measured by thermometer.<br><br><br>[1 week, 2 weeks (primary timepoint) & 1 month after intervention commencement. <br>2 weeks and 12 weeks after end of intervention.];(Safety outcome)<br>Change from baseline in clinical ocular examination: intraocular pressure measured using Tono-Pen.[1 week, 2 weeks (primary timepoint) & 1 month after intervention commencement. <br>2 weeks and 12 weeks after end of intervention.]
- Secondary Outcome Measures
Name Time Method