A Study to Investigate the Safety and Clinical Effect of Nexagon® to Treat Persistent Epithelial Defects

Launched by OCUNEXUS THERAPEUTICS, INC. · Jan 12, 2009

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Eligibility criteria

• Inclusion Criteria:
• • 1. Male and female subjects aged 18 years and over.
• • 2. Subjects who are able to attend all follow-up visits and who are able to comply with all study procedures.
• • 3. Subjects who are willing and able to give written informed consent to take part in the study.
• • 4. 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.
• • 5. The original defect to the cornea must have been caused by either alkaline or acidic agents.
• Exclusion Criteria:
• • 1. Use of concomitant ocular medications in the screening period that are not specified in standardized PED treatment regime
• • 2. 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
• • 3. Decrease or increase in the PED by more than 30% during the screening period.
• • 4. Have an active lid or ocular infectious process of any sort
• • 5. Subjects with corneal perforation or impending corneal perforation
• • 6. The circumference affected by limbal blood vessel ischemia is greater than 75% of the circumference
• • 7. Subjects with severe lid abnormalities contributory to the persistence of the PED such as inability to close the lids.
• • 8. Subjects with bilateral PED, if the smaller PED has a longest diameter of \> 2 mm.
• • 9. Female subjects who are pregnant or breastfeeding. F
• • 10. Subjects who have a history of AIDS or HIV.
• • 11. Subjects with any other condition which, in the Investigator's opinion, would exclude the subject from participating.
• • 12. 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
• • 13. Subjects who have participated in a clinical trial within 30 days prior to Day 0.
• • 14. Diabetics with an HbA1c greater than 6.5%.
• • 15. Diabetics who are currently prescribed more than one oral medication for their diabetes.
• • 16. Subjects who have more than one distinct PED in the study eye.