University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Location status: Recruiting
NCT Number: NCT06919081
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Chicago, Illinois, 60612, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Eye Drops
Eye Drops
Time frame: 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
Time frame: Baseline to Day 56
Percent change in best-corrected distance visual acuity from baseline to DAY 56 as measured using standard ETDRS protocols
Time frame: Baseline to Day 70
Grading of fluorescein staining of the cornea Minimum score = 0 Maximum score = 15 Lower score is better
Time frame: 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
Time frame: 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)
Time frame: 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 frame: Baseline to Day 70
Time of improvement of epitheliopathy
Time frame: 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
Time frame: Baseline to Day 56
Change in corneal vascularization on slit lamp photographs from baseline to DAY 56
Time frame: Baseline to Day 56
Change in conjunctival injection on slit lamp examination from baseline to DAY 56
Time frame: Baseline to Day 56
Changes in subbasal corneal nerve density on confocal microscopy from baseline to Day 56
Time frame: Baseline to Day 70
Changes in Lissamine green staining from baseline to DAY 56 and DAY 70
Time frame: Baseline to Day 70
Changes in anesthetic Schirmer's test from baseline to DAY 56 and DAY 70
Contact information is provided by the study sponsor or research team.
Ali R Djalilian, MD
CONTACT
Charlotte E Joslin, OD
CONTACT
University of Illinois at Chicago
Other
Phase II Study of the Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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