A Study to Investigate the Safety and Clinical Effect of Nexagon® to Treat Persistent Epithelial … (NCT00821561) | Clinical Trial Compass
WithdrawnPhase 2
A Study to Investigate the Safety and Clinical Effect of Nexagon® to Treat Persistent Epithelial Defects
Stopped: Withdrawn prior to recruitment for business reasons.
90 participantsStarted 2009-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. Male and female subjects aged 18 years and over.
âś“. Subjects who are able to attend all follow-up visits and who are able to comply with all study procedures.
âś“. Subjects who are willing and able to give written informed consent to take part in the study.
âś“. 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.
âś“. The original defect to the cornea must have been caused by either alkaline or acidic agents.
Exclusion criteria
âś•. Use of concomitant ocular medications in the screening period that are not specified in standardized PED treatment regime
âś•. 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
âś•. Decrease or increase in the PED by more than 30% during the screening period.
âś•. Have an active lid or ocular infectious process of any sort
âś•. Subjects with corneal perforation or impending corneal perforation
âś•. The circumference affected by limbal blood vessel ischemia is greater than 75% of the circumference
What they're measuring
1
The primary objective of this study is to evaluate the efficacy and safety of Nexagon® as a treatment for PED from chemical burn injuries.