ST266 Eye Drops for the Treatment of Persistent Corneal Epithelial Defects (NCT03687632) | Clinical Trial Compass
CompletedPhase 2
ST266 Eye Drops for the Treatment of Persistent Corneal Epithelial Defects
United States13 participantsStarted 2019-06-10
Plain-language summary
The primary aim of the study is to evaluate the clinical response of ST266 treated subjects with persistent corneal epithelial defects during 28 days of therapy. The secondary endpoint is the response rate within 14 days of treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male and female subjects aged 18 years and over.
* Subjects with a PED present for at least seven (7) days.
* The defect may be of any size and must be measurable by slit lamp.
* 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 be the result of any injury, infection, disease or surgery to the eye.
Exclusion Criteria:
* Subjects currently being treated with cenegermin.
* Subjects who require treatment with autologous serum eyedrops throughout the duration of the trial. If, in the opinion of the investigator, autologous serum eyedrop treatment can be safely stopped, the subject may be included in the clinical trial.
* Subjects who require treatment with other amnion products throughout the duration of the trial. If, in the opinion of the investigator, the amniotic product treatment can be safely stopped, the subject may be included in the clinical trial.
* Subject who requires treatment with amniotic membrane throughout the duration of the trial. If the amniotic membrane can be safely stopped, the subject may be included in the clinical trial. Note: The amniotic membrane must be removed at least one (1) day prior to the baseline visit.
* Subjects who require treatment with bandage contact lens that cannot be removed at least 24 hours prior to screening. If the bandage contact lens …
What they're measuring
1
Proportion of subjects with complete healing of PED during 28 days of treatment starting