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

February 24, 2010 updated by: OcuNexus Therapeutics, Inc.

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.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary objective of this study is to evaluate the efficacy and safety of Nexagon® as a treatment for PED from chemical burn injuries.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OcuNexus Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ANTICIPATED)

November 1, 2009

Study Completion (ANTICIPATED)

March 1, 2010

Study Registration Dates

First Submitted

January 10, 2009

First Submitted That Met QC Criteria

January 12, 2009

First Posted (ESTIMATE)

January 13, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 26, 2010

Last Update Submitted That Met QC Criteria

February 24, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NEX-PED-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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