Clinical trial NCT05727878: Trial to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With PCED
Official title: A Study to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With Persistent Corneal Epithelial Defect (PCED)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Persistent Corneal Epithelial Defect
Lead sponsor: Kala Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Kala Pharmaceuticals, Inc.
First posted: 2023-02-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Response status
timeFrame: Day 56
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Principal Investigator
state: Alabama
city: Irvine
country: United States
facility: Principal Investigator
state: California
city: La Jolla
country: United States
facility: Principal Investigator
state: California
city: Loma Linda
country: United States
facility: Principal Investigator
state: California
city: Los Angeles
country: United States
facility: Principal Investigator
state: California
city: Los Angeles
country: United States
facility: Principal Investigator
state: California
city: Pasadena
country: United States
facility: Principal Investigator
state: California
city: Rancho Cordova
country: United States
facility: Principal Investigator
state: California
city: Aurora
country: United States
facility: Principal Investigator
state: Colorado
city: Fort Collins
country: United States
facility: Principal Investigator
state: Colorado
city: Littleton
country: United States
facility: Principal Investigator
state: Colorado
city: Miami
country: United States
facility: Principal Investigator
state: Florida
city: Miami
country: United States
facility: Principal Investigator
state: Florida
city: Orange City
country: United States
facility: Principal Investigator
state: Florida
city: Atlanta
country: United States
facility: Principal Investigator
state: Georgia
city: Carmel
country: United States
facility: Principal Investigator
state: Indiana
city: Indianapolis
country: United States
facility: Principal Investigator
state: Indiana
city: Louisville
country: United States
facility: Principal Investigator
state: Kentucky
city: Boston
country: United States
facility: Principal Investigator
state: Massachusetts
city: Boston
country: United States
facility: Principal Investigator
state: Massachusetts
city: Chesterfield
country: United States
facility: Principal Investigator
state: Missouri
city: Kansas City
country: United States
facility: Principal Investigator
state: Missouri
city: Kansas City
country: United States
facility: Principal Investigator
state: Missouri
city: Saint Louis
country: United States
facility: Principal Investigator
state: Missouri
city: Palisades Park
country: United States
facility: Principal Investigator
state: New Jersey
city: New York
country: United States
facility: Principal Investigator
state: New York
city: Rockville Centre
country: United States
facility: Principal Investigator
state: New York
city: Durham
country: United States
facility: Principal investigator
state: North Carolina
city: Garner
country: United States
facility: Principal Investigator
state: North Carolina
city: Powell
country: United States
facility: Principal Investigator
state: Ohio
city: Philadelphia
country: United States
facility: Principal Investigator
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Principal Investigator
state: Pennsylvania
city: Rapid City
country: United States
facility: Principal Investigator
state: South Dakota
city: Memphis
country: United States
facility: Principal Investigator
state: Tennessee
city: Nashville
country: United States
facility: Principal Investigator
state: Tennessee
city: Austin
country: United States
facility: Principal Investigator
state: Texas
city: Austin
country: United States
facility: Principal Investigator
state: Texas
city: Houston
country: United States
facility: Principal Investigator
state: Texas
city: San Antonio
country: United States
facility: Principal Investigator
state: Texas
city: Norfolk
country: United States
facility: Principal Investigator
state: Virginia
city: Seattle
country: United States
facility: Principal Investigator
state: Washington
city: Morgantown
country: United States
facility: Principal Investigator
state: West Virginia
city: Kenosha
country: United States
facility: Principal Investigator
state: Wisconsin
city: Caba
country: Argentina
facility: Principal Investigator
state: Buenos Aires
city: Rosario
country: Argentina
facility: Principal Investigator
state: Santa Fe
city: Rosario
country: Argentina
facility: Principal Investigator
state: Santa Fe
city: San Juan
country: Puerto Rico
facility: Principal Investigator
Study officials:
affiliation: Kala Pharmaceuticals, Inc.
name: Kristie Veasey
role: STUDY_DIRECTOR
References: