Evaluation of the Safety and Efficacy of CMB-012 in Subjects with Chemical Burns of the Cornea and/or Persistent Corneal Epithelial Defects (PCED)

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)

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001724167

Enrollment

Registered

2019-12-06

Start date

2020-02-24

Completion date

2020-04-06

Last updated

2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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).

Outcome results