Clinical trial NCT05436288: A Study of the KIO-201 (Ocular Bandage Gel) for Improving Persistent Corneal Epithelial Defects
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Persistent Corneal Epithelial Defect
Lead sponsor: Kiora Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 refractory to one or more conventional non-surgical treatments of at least 2 weeks) will receive KIO-201 with a dosing regimen of six (6) times per day over 4 weeks.

Both eyes are to be included if both eyes meet inclusion criteria and both eyes will be treated with KIO-201.

Patients will followed for a 4 week study.

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.

Primary outcomes:
measure: Percentage of Patients Achieving Corneal Healing (<0.5 mm2 Lesion Size) of the Persistent Corneal Epithelial Defect at 4 Weeks
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto de Oftalmología Fundación Conde de Valenciana
state: Chimalpopoca 14 Colonia Obrera
Study officials:
affiliation: Instituto de Oftalmología Fundación Conde de Valenciana
name: Enrique Graue, M.D.
role: PRINCIPAL_INVESTIGATOR
References: