Clinical trial

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)

Name

OBG PED-001

Description

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.

Trial arms

Trial start

2022-07-01

Estimated PCD

2022-12-22

Trial end

2023-01-22

Status

Completed

Phase

Early phase I

Treatment

KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S)

KIO-201 is a stand-alone drug therapy that acts as a barrier that minimizes mechanical lid friction and mechanically protects the ocular surface thereby reducing repeat injury and providing an environment that enables the body to repair the ocular surface whether the corneal epithelial defects are large or small.

Arms:

Single arm active

Size

Primary endpoint

Percentage of Patients Achieving Corneal Healing (<0.5 mm2 Lesion Size) of the Persistent Corneal Epithelial Defect at 4 Weeks

4 weeks

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}

Updated at

2024-04-03

1 organization

1 product

1 indication

Organization

Kiora Pharmaceuticals

Product

KIO-201

Indication

Persistent Corneal Epithelial Defect