Persistent Corneal Epithelial Defect Clinical Trial
Official title:
A Pilot Study of the Safety and Effectiveness of the EyeGate Ocular Bandage Gel, a 0.75% Crosslinked Hyaluronic Acid Applied Topically for the Improvement of Persistent Corneal Epithelial Defects (PED)
Verified date | March 2024 |
Source | Kiora Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 day while awake for 4 weeks. The primary exploratory effectiveness outcome for this study is the percentage of patients achieving corneal healing as determined by corneal fluorescein staining and photos. The effectiveness endpoint will be evaluated by a reader using digital photography of fluorescein stained slit lamp photos and image analysis.
Status | Completed |
Enrollment | 10 |
Est. completion date | January 22, 2023 |
Est. primary completion date | December 22, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto de Oftalmología Fundación Conde de Valenciana | Mexico City | Chimalpopoca 14 Colonia Obrera |
Lead Sponsor | Collaborator |
---|---|
Kiora Pharmaceuticals, Inc. |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Patients Achieving Corneal Healing (<0.5 mm2 Lesion Size) of the Persistent Corneal Epithelial Defect at 4 Weeks | Determined by corneal fluorescein staining and the effectiveness endpoint will also be evaluated by a reader using digital photography of fluorescein stained slit lamp photos and image analysis. | 4 weeks |
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