Status:
COMPLETED
A Study of the KIO-201 (Ocular Bandage Gel) for Improving Persistent Corneal Epithelial Defects
Lead Sponsor:
Kiora Pharmaceuticals, Inc.
Conditions:
Persistent Corneal Epithelial Defect
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the safety and effectiveness of topical KIO-201 in patients with persistent corneal epithelial defects (PED). KIO-201 will be administered six (6) times per ...
Detailed Description
This is a prospective, exploratory study in which up to 10 patients (up to 20 eyes \[minimum of 10 eyes\]) diagnosed with Stage 1 and Stage 2 PED (as defined by fluorescein staining of the cornea and ...
Eligibility Criteria
Inclusion
- Patients 18 years of age or older.
- Patients with persistent corneal epithelial defects (PED) (Stage 1 and Stage 2 PED).
- Patients with PED in one or both eyes, at least one eye meeting all study criteria.
- Have PED of at least 2 weeks' duration refractory to one or more conventional non-surgical treatments for Stage 1 and Stage 2 PED (i.e., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops).
Exclusion
- Have any active ocular infection (bacterial, viral, fungal or protozoal) in the affected eye(s).
- Schirmer's test without anesthesia ≤ 3 mm/ 5 minutes in the affected eye(s).
- Patients who have received amniotic membrane transplantation and have not healed.
- Patients treated with a bandage contact lens but have not healed.
- Prior surgical procedure(s) for the treatment of PED in the affected eye(s).
- Patients with lid abnormalities.
- Corneal disease that may affect outcomes.
- Stage 3 PED.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05436288
Start Date
July 1 2022
End Date
January 22 2023
Last Update
April 3 2024
Active Locations (1)
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1
Instituto de Oftalmología Fundación Conde de Valenciana
Mexico City, Chimalpopoca 14 Colonia Obrera, Mexico, 06800