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A Study of the KIO-201 (Ocular Bandage Gel) for Improving Persistent Corneal Epithelial Defects

NCT05436288 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-04-03

Study results available
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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.

Conditions

  • Persistent Corneal Epithelial Defect

Interventions

DRUG

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.

Sponsors & Collaborators

  • Kiora Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Enrique Graue, M.D. · Instituto de Oftalmología Fundación Conde de Valenciana

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2022-12-22
Completion
2023-01-22
FDA Drug
Yes

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05436288 on ClinicalTrials.gov