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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Persistent Corneal Epithelial Defect
• Intervention / Treatment: Drug: KPI-012; Drug: KPI-012 Vehicle

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 2
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kala Clinical Development; Phone Number: 781-996-5252; Email: kristie.veasey@kalarx.com

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 334-456-5511
  • California
    • Irvine, California, United States, 92897
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 949-824-8297
    • La Jolla, California, United States, 92037
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 858-554-9611
    • Loma Linda, California, United States, 92354
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 909-558-2230
    • Los Angeles, California, United States, 90013
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 213-680-1551
    • Pasadena, California, United States, 91107
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 6 626-793-4168
    • Rancho Cordova, California, United States, 95670
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 916-631-7860
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 970-837-3273
    • Littleton, Colorado, United States, 80120
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 130 303-730-0404
  • Florida
    • Miami, Florida, United States, 33143
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 1740 305-661-8588
  • Georgia
    • Atlanta, Georgia, United States, 30339
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 1173 404-351-2220
  • Indiana
    • Carmel, Indiana, United States, 46290
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 317-805-4527
    • Indianapolis, Indiana, United States, 46260
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 317-814-2996
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Recruiting
      • Principal Investigator
      • Contact: Research Coordinator; Phone Number: 502-219-7700
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 617-636-1051
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Recruiting
      • Principal Investigator
      • Contact: Research Coordinator; Phone Number: 636-534-5126
    • Kansas City, Missouri, United States, 64111
      • Recruiting
      • Principal Investigator
      • Contact: Research Coordinator; Phone Number: 816-531-9100
    • Kansas City, Missouri, United States, 64133
      • Recruiting
      • Principal Investigator
      • Contact: Research Coordinator; Phone Number: 816-595-3907
    • Saint Louis, Missouri, United States, 63131
      • Recruiting
      • Principal Investigator
      • Contact: Research Coordinator; Phone Number: 314-966-3377
  • New York
    • New York, New York, United States, 10036
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 212-938-4052
    • Rockville Centre, New York, United States, 11570
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 516-593-4026
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 919-681-1569
    • Garner, North Carolina, United States, 27529
      • Recruiting
      • Principal Investigator
      • Contact: Research Coordinator; Phone Number: 919-346-6945
  • Ohio
    • Powell, Ohio, United States, 43065
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 614-793-0700
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 215-825-4722
    • Pittsburgh, Pennsylvania, United States, 15219
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 412-647-3434
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 605-719-3204
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Active, not recruiting
      • Principal Investigator
    • Nashville, Tennessee, United States, 37215
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 615-327-4015
  • Texas
    • Austin, Texas, United States, 78731
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 512-451-4400
    • Houston, Texas, United States, 77030
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 713-798-8496
    • San Antonio, Texas, United States, 78212
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 210-600-0040
  • Washington
    • Seattle, Washington, United States, 98119
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 206-347-0821
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142
      • Recruiting
      • Principal Investigator
      • Contact: Study Coordinator; Phone Number: 262-898-5677

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1, Arm 1; KPI-012 High Dose KPI-012 Ophthalmic Solution 3 U/mL 1 drop 4 times/day for 56 days	Drug: KPI-012; KPI-012 is a secretome product composed of biologically active components secreted from human bone marrow-derived mesenchymal stem cells
Experimental: Cohort 2, Arm 1; KPI-012 Low Dose KPI-012 Ophthalmic Solution 1 U/mL 1 drop 4 times/day for 56 days	Drug: KPI-012; KPI-012 is a secretome product composed of biologically active components secreted from human bone marrow-derived mesenchymal stem cells
Experimental: Cohort 2, Arm 2; KPI-012 High Dose KPI-012 Ophthalmic Solution 3 U/mL 1 drop 4 times/day for 56 days	Drug: KPI-012; KPI-012 is a secretome product composed of biologically active components secreted from human bone marrow-derived mesenchymal stem cells
Placebo Comparator: Cohort 2, Arm 3; KPI-012 Vehicle KPI-012 Ophthalmic Solution 0 U/mL 1 drop 4 times/day for 56 days	Drug: KPI-012 Vehicle; KPI-012 formulation with no active drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response status	Complete healing of the PCED and no corneal fluorescein staining in the area of the study lesion.	Day 56

Collaborators and Investigators

• Sponsor: Combangio, Inc
• Collaborators: Kala Pharmaceuticals, Inc.
• Investigators: Study Director: Kristie Veasey, Kala Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: KPI-012-C-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No