Status:
RECRUITING
Secretome Clinical Trial
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
National Eye Institute (NEI)
National Institutes of Health (NIH)
Conditions:
Persistent Corneal Epithelial Defect
Corneal Epithelial Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06919081
Start Date
August 1 2025
End Date
June 15 2026
Last Update
October 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612