Status:
TERMINATED
Efficacy and Safety Study of Nexagon for Persistent Corneal Epithelial Defects
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
FDA Office of Orphan Products Development
Conditions:
Persistent Corneal Epithelial Defects
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 corneal epithelial defects (PED) resulting from corneal epithelial debridement during diabetic ...
Detailed Description
The purpose of this prospective, randomized, double-masked, vehicle-controlled, dose-escalation study is to evaluate the efficacy and safety of Nexagon® in subjects with persistent corneal epithelial ...
Eligibility Criteria
Inclusion
- Male and female subjects aged 18 years and over.
- Female subjects must be a) postmenopausal, b) surgically sterilized, c) practicing abstinence, or d) using a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide for the duration of the study.
- 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.
- Subjects with a PED, defined as follows: "a corneal epithelial defect persisting for at least 14 days and not longer than 28 days."
- In the Investigator's opinion, the defect is persistent i.e., the defect has not shown improvement despite conventional treatment such as tear supplements and bandage contact lenses.
- The original defect to the cornea must have resulted from corneal epithelial debridement during diabetic vitrectomy surgery, HSV keratitis, HZV keratitis, corneal burns, post-PRK, or post-corneal transplant surgery.
Exclusion
- Use of concomitant ocular medications in the screening period that are not specified in standardized PED treatment regimen
- 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 50% during the screening period.
- Have an active eyelid or ocular infectious process of any sort, in the opinion of the Investigator.
- Subjects with corneal perforation or impending corneal perforation.
- Subjects with severe eyelid abnormalities contributory to the persistence of the PED.
- Subjects with bilateral PED, if the smaller PED has a longest diameter of \> 2 mm. (Note: if bilateral PED is present and the smaller PED is \< 2 mm, the subject is eligible. In this situation only the eye with the larger PED should be entered into the study).
- Female subjects who are pregnant or breastfeeding. Female subjects who are neither postmenopausal nor surgically sterile require a negative urine pregnancy test on Day 0 (plus or minus 1 day) visit.
- 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 (plus or minus 1 day) visit, 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 (plus or minus 1 day) visit.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01165450
Start Date
November 1 2011
End Date
February 1 2014
Last Update
May 7 2015
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