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Evaluating a new eye treatment for persistent corneal epithelial defect

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

PHASE2 · Kala Pharmaceuticals, Inc. · NCT05727878

This study is testing a new eye treatment called KPI-012 to see if it can help people with a stubborn eye condition called persistent corneal epithelial defect heal better than a placebo.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment90 (estimated)
Ages18 Years and up
SexAll
SponsorKala Pharmaceuticals, Inc. (industry)
Locations47 sites (Dothan, Alabama and 46 other locations)
Trial IDNCT05727878 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and efficacy of KPI-012, a topical mesenchymal stem cell secretome therapy, in participants diagnosed with persistent corneal epithelial defect (PCED). Approximately 90 participants will be enrolled across multiple US centers, with an initial cohort evaluating the safety of the high strength product. Following this, participants will be randomized to receive either KPI-012 or a placebo for 8 weeks, with the primary outcome being the percentage of healing compared between the two groups. The total duration of participation for each participant will be around 34 weeks.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with PCED for at least 7 days due to various underlying conditions.

Not a fit: Patients with active ocular infections or severe corneal conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing outcomes for patients suffering from persistent corneal epithelial defects.

How similar studies have performed: While this approach is novel, similar studies using stem cell therapies have shown promise in other ocular conditions.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Dothan, Alabama and 46 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Persistent Corneal Epithelial Defect

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.