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

Persistent Epithelial Defect Clinical Trial

Official title:

A Phase 2, Randomized, Prospective, Double-masked, Vehicle-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Nexagon® in Subjects With Persistent Corneal Epithelial Defects (PED) From Chemical Burn Injuries.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00821561
• Other study ID #: NEX-PED-001
• Status: Withdrawn
• Phase: Phase 2
• First received: January 10, 2009
• Last updated: February 24, 2010
• Start date: March 2009
• Est. completion date: March 2010

Study information

• Verified date: February 2010
• Source: CoDa Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 90
• Est. completion date: March 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Persistent Epithelial Defect

Intervention

Drug:
• Nexagon®

• Nexagon® vehicle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CoDa Therapeutics Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study is to evaluate the efficacy and safety of Nexagon® as a treatment for PED from chemical burn injuries.