Corneal Epithelial Disorders, Persistent Corneal Epithelial Defect
Conditions
Keywords
persistent corneal epithelial disease/defects, persistent corneal epithelial, corneal epithelial disease, limbal stem cell deficiency, neurotrophic keratitis
Brief summary
In this phase II randomized double-masked clinical trials, subjects with non-resolving corneal epithelial disease/defect (i.e., refractory to standard treatments for at least two weeks) will receive 8 weeks treatment of topical mesenchymal stem cell secretome or vehicle, with continued follow-up for up to Day 70.
Interventions
DRUGAllogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome
Eye Drops
OTHERVehicle Control
Eye Drops
Sponsors
University of Illinois at Chicago
National Eye Institute (NEI)
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age · Patients 18 years of age or older * Ocular Health * Chronic corneal epithelial disease with fluorescein staining score 6 by NEI grading scale or persistent corneal epithelial defect present for longer than 14 days despite standard treatment * No objective clinical evidence of significant (\> 50%) improvement/worsening of the epithelial disease in the last 14 days * Epithelial disease refractory to conventional non-surgical treatments (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops; anti-inflammatory therapy) * If both eyes of subject meet the inclusion criteria, the eye with the higher fluorescein staining score will be enrolled to the study. * Study Procedures * Only patients who satisfy all Informed Consent requirements may be included in the study. The patient and/or his/her legal representative must read, sign and date the Informed Consent document before any study-related procedures are performed. The Informed Consent form signed by patients and/or legal representative must have been approved by the UIC IRB for the current study. Patients must have the ability and willingness to comply with study procedures.
Exclusion criteria
* Ocular Health * Any active or suspected ocular infection (bacterial, viral, fungal or protozoal). * History of any ocular surgery (including laser or refractive surgical procedures) in the study eye within the 3 months prior to study enrollment. * Treatment with Oxervate in the study eye within 12 months of enrollment. * Study Procedures * Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein). * Use of any investigational agent within 4 weeks of screening visit. * Participation in another clinical study at the same time as the present study. * Participants who are pregnant at the time of study enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Corneal Epithelial Barrier and/or Integrity (Efficacy Outcome) | Baseline to Day 56 | Proportion of subjects with improved epithelial barrier and/or integrity from baseline to DAY 56 as determined by the investigator on slit lamp examination: · Improved epithelial barrier, defined as ³ 50 % improvement in corneal fluorescein staining score using NEI grading scale · Improved epithelial integrity, defined as complete closure of persistent epithelial defect, measured with ImageJ on slit lamp images |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Opacities/Scars | Baseline to Day 56 | Change in the size of corneal opacities and scars (if present) from baseline to DAY 56 as documented by slit lamp photographs |
| Corneal vascularization | Baseline to Day 56 | Change in corneal vascularization on slit lamp photographs from baseline to DAY 56 |
| Visual Acuity | Baseline to Day 56 | Percent change in best-corrected distance visual acuity from baseline to DAY 56 as measured using standard ETDRS protocols |
| Corneal staining and NEI grading | Baseline to Day 70 | Grading of fluorescein staining of the cornea Minimum score = 0 Maximum score = 15 Lower score is better |
| Ocular Surface Parameters | Baseline to Day 70 | Changes in ocular surface disease index (OSDI) from baseline to DAY 56 and DAY 70 Minimum value = 0 Maximum value = 100 Lower value is better |
| Corneal Epithelial Thickness | Baseline to Day 70 | Percent change in corneal epithelial thickness from baseline to DAY 56 and DAY 70, as measured by anterior segment OCT (AS-OCT) |
| Subject Symptoms | Baseline to Day 70 | Changes in ocular discomfort visual analog scale (VAS) 0 - 100, where 0 is no discomfort and 100 the worst discomfort, from baseline to DAY 70 |
| Time to epithelial healing | Baseline to Day 70 | Time of improvement of epitheliopathy |
| Subbasal corneal nerve density | Baseline to Day 56 | Changes in subbasal corneal nerve density on confocal microscopy from baseline to Day 56 |
| Conjunctival injection | Baseline to Day 56 | Change in conjunctival injection on slit lamp examination from baseline to DAY 56 |
Countries
United States
Contacts
CONTACTAli R Djalilian, MD
CONTACTCharlotte E Joslin, OD
PRINCIPAL_INVESTIGATORAli R Djalilian, MD
University of Illinois at Chicago
Outcome results
None listed