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

NCT05436288 | Completed Phase 2 Results FDA Drug

• 1 other identifier: OBG PED-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Corneal Epithelial Defect

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Single arm active

EXPERIMENTAL

KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S), up to 6 times a day for 4 weeks.

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

Interventions

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

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.

Single arm active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kiora Pharmaceuticals, Inc.: lead

Study Sites (1)

Instituto de Oftalmología Fundación Conde de Valenciana

Mexico City, Chimalpopoca 14 Colonia Obrera, 06800, Mexico

Location

Results Point of Contact

• Title: Eric Daniels
• Organization: Kiora Pharmaceuticals, Inc.

edaniels@kiorapharma.com

858-353-0469

Study Officials

• Enrique Graue, M.D.

  Instituto de Oftalmología Fundación Conde de Valenciana

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: July 1, 2022
• Primary Completion: December 22, 2022
• Study Completion: January 22, 2023
• Last Updated: April 3, 2024
• Results First Posted: April 3, 2024

Record last verified: 2024-03

Locations

ME (1)