Trial to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With PCED

Persistent Corneal Epithelial Defect Clinical Trial

— CHASE  

Official title:

A Study to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With Persistent Corneal Epithelial Defect (PCED)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05727878
• Other study ID #: KPI-012-C-001
• Status: Recruiting
• Phase: Phase 2
• Start date: February 7, 2023
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: Kala Pharmaceuticals, Inc.
• Contact: Kala Clinical Development
• Phone: 781-996-5252
• Email: kristie.veasey[@]kalarx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to investigate the safety and efficacy of KPI-012 compared to vehicle in participants who have a documented clinical diagnosis of PCED.

Description:

Approximately 90 participants diagnosed with persistent corneal epithelial defect (PCED) will be enrolled at multiple US centers in a study to assess the safety and efficacy of KPI-012, a topical mesenchymal stem cell secretome therapy. After an initial cohort of at least 2 participants to evaluate the safety of the high strength product, participants in the second cohort will be randomized to treatment with either the product or vehicle (placebo) for 8 weeks. The percentage of healing will be compared between groups treated with product and vehicle. Total length of study participation will be approximately 34 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: August 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Have PCED for at least 7 days prior due to an underlying condition such as diabetic keratopathy, herpetic eye disease, severe dry eye disease, limbal stem cell deficiency, infectious keratitis, neurotrophic keratitis, post ocular surgery, medical trauma, chemical burn, etc.

2. PCED measurements meet study criteria.

Exclusion Criteria:

1. Any active ocular infection or any active infectious disease that could impact the PCED.

2. Severe corneal burns in the Study Eye.

3. Severe limbal stem cell deficiency in either eye.

4. The circumference affected by limbal blood vessel ischemia greater than 75% of the circumference in the Study Eye.

5. Severe blepharitis or severe meibomian gland disease.

6. Severe eyelid abnormalities in the Study Eye, contributory to the persistence of the PCED.

7. Evidence of corneal ulceration.

8. Anticipated need for punctal occlusion.

9. Use of Oxervate in the Study Eye within past 30 days.

10. History of any surgical procedure for treatment of the study PCED.

11. History of any other ocular surgery in the Study Eye within 90 days prior to screening.

12. Not willing to suspend use of contact lens in the Study Eye.

13. Any use of Botox injections to induce pharmacologic blepharoptosis in the 90 days.

14. Expected use of systemic doxycycline.

15. Any use of chemotherapeutic agents within 7 days prior to Study, or anticipated use during the study.

16. History of current drug or alcohol abuse or addiction.

17. Use of another investigational agent within 30 days.

18. Participants who are pregnant, breastfeeding, or planning a pregnancy during the study.

Related Conditions & MeSH terms

• Persistent Corneal Epithelial Defect

Intervention

Drug:
• KPI-012
KPI-012 is a secretome product composed of biologically active components secreted from human bone marrow-derived mesenchymal stem cells
• KPI-012 Vehicle
KPI-012 formulation with no active drug

Locations

Country	Name	City	State
United States	Principal Investigator	Atlanta	Georgia
United States	Principal Investigator	Austin	Texas
United States	Principal Investigator	Boston	Massachusetts
United States	Principal Investigator	Carmel	Indiana
United States	Principal Investigator	Chesterfield	Missouri
United States	Principal Investigator	Dothan	Alabama
United States	Principal investigator	Durham	North Carolina
United States	Principal Investigator	Fort Collins	Colorado
United States	Principal Investigator	Garner	North Carolina
United States	Principal Investigator	Houston	Texas
United States	Principal Investigator	Indianapolis	Indiana
United States	Principal Investigator	Irvine	California
United States	Principal Investigator	Kansas City	Missouri
United States	Principal Investigator	Kansas City	Missouri
United States	Principal Investigator	Kenosha	Wisconsin
United States	Principal Investigator	La Jolla	California
United States	Principal Investigator	Littleton	Colorado
United States	Principal Investigator	Loma Linda	California
United States	Principal Investigator	Los Angeles	California
United States	Principal Investigator	Louisville	Kentucky
United States	Principal Investigator	Memphis	Tennessee
United States	Principal Investigator	Miami	Florida
United States	Principal Investigator	Nashville	Tennessee
United States	Principal Investigator	New York	New York
United States	Principal Investigator	Pasadena	California
United States	Principal Investigator	Philadelphia	Pennsylvania
United States	Principal Investigator	Pittsburgh	Pennsylvania
United States	Principal Investigator	Powell	Ohio
United States	Principal Investigator	Rancho Cordova	California
United States	Principal Investigator	Rapid City	South Dakota
United States	Principal Investigator	Rockville Centre	New York
United States	Principal Investigator	Saint Louis	Missouri
United States	Principal Investigator	San Antonio	Texas
United States	Principal Investigator	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Combangio, Inc	Kala Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response status	Complete healing of the PCED and no corneal fluorescein staining in the area of the study lesion.	Day 56