ST266 Eyedrops for the Treatment of Persistent Corneal Epithelial Defects
NCT05066698 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2022-10-25
Summary
The primary objective is to determine the efficacy of ST266 eye drops in healing persistent epithelial defects (PED). After 8 weeks of randomized, double-blind treatment, non-healers will enter into an additional 8-week open-label ST266 treatment period. All patients will be followed for 3-months post-treatment for monitoring of safety and maintenance of re-epithelialization.
Conditions
- Persistent Corneal Epithelial Defect
Interventions
- BIOLOGICAL
-
ST266
Topical ocular application: one drop four times a day for eight weeks
- OTHER
-
0.67% Sodium Chloride Ophthalmic Solution
Topical ocular application: one drop four times a day for eight weeks
- BIOLOGICAL
-
Open-label ST266
Open label extension for non-healers after completion of double-blind treatment phase: topical ocular application of one drop four times a day for eight weeks
Sponsors & Collaborators
-
IQVIA Biotech
collaborator INDUSTRY -
Noveome Biotherapeutics, formerly Stemnion
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-27
- Primary Completion
- 2022-09-07
- Completion
- 2022-09-07
- FDA Drug
- Yes
Countries
- United States
Study Locations
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