Status:
WITHDRAWN
A Study to Investigate the Safety and Clinical Effect of Nexagon® to Treat Persistent Epithelial Defects
Lead Sponsor:
OcuNexus Therapeutics, Inc.
Conditions:
Persistent Epithelial Defect
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Nexagon® in subjects with Persistent Epithelial Defects (PED) originally caused by chemical burns.
Eligibility Criteria
Inclusion
- Male and female subjects aged 18 years and over.
- Subjects who are able to attend all follow-up visits and who are able to comply with all study procedures.
- Subjects who are willing and able to give written informed consent to take part in the study.
- At the Day -7 visit subjects must have a corneal epithelial defect that has persisted for between 7 days and 14 days, which has a minimum diameter of 2 mm along the greatest axis, and which has not shown improvement despite conventional treatment such as tear supplements and bandage contact lenses.
- The original defect to the cornea must have been caused by either alkaline or acidic agents.
Exclusion
- Use of concomitant ocular medications in the screening period that are not specified in standardized PED treatment regime
- Likely to require the use of concomitant ocular medications that are not specified in the standardized PED treatment regime during the study follow-up period
- Decrease or increase in the PED by more than 30% during the screening period.
- Have an active lid or ocular infectious process of any sort
- Subjects with corneal perforation or impending corneal perforation
- The circumference affected by limbal blood vessel ischemia is greater than 75% of the circumference
- Subjects with severe lid abnormalities contributory to the persistence of the PED such as inability to close the lids.
- Subjects with bilateral PED, if the smaller PED has a longest diameter of \> 2 mm.
- Female subjects who are pregnant or breastfeeding. F
- Subjects who have a history of AIDS or HIV.
- Subjects with any other condition which, in the Investigator's opinion, would exclude the subject from participating.
- Treatment with systemic corticosteroids (equivalent to \> 10 mg/day of prednisone) or immunosuppressive or chemotherapeutic agents within 7 days prior to Day 0, or likely to receive one of these therapies during study participation
- Subjects who have participated in a clinical trial within 30 days prior to Day 0.
- Diabetics with an HbA1c greater than 6.5%.
- Diabetics who are currently prescribed more than one oral medication for their diabetes.
- Subjects who have more than one distinct PED in the study eye.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00821561
Start Date
March 1 2009
End Date
March 1 2010
Last Update
February 26 2010
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