Phase 2
N=10
A Study of the KIO-201 (Ocular Bandage Gel) for Improving Persistent Corneal Epithelial Defects
Persistent Corneal Epithelial Defect
Bottom Line
View on ClinicalTrials.gov: NCT05436288 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Percentage of Patients Achieving Corneal Healing (<0.5 mm2 Lesion Size) of the Persistent Corneal Epithelial Defect at 4 Weeks — 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kiora Pharmaceuticals, Inc.
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Achieving Corneal Healing (<0.5 mm2 Lesion Size) of the Persistent Corneal Epithelial Defect at 4 Weeks |
5 | — |
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 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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05436288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.