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Efficacy/Safety of Human Plasminogen Eye Drop in Ligneous Conjunctivitis Patients

NCT01554956 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-01-25

Study results available
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Summary

Kedrion Human Plasminogen, a sterile human plasma-derived plasminogen preparation for topical ocular use will be evaluated for the indication of treatment of ligneous conjunctivitis.

KB046 will be an open-label, historically controlled clinical trial. At least 10 subjects with ligneous conjunctivitis, for approximately 20 eyes, will be treated and assessed. All subjects will receive the investigational medicinal product (IMP) for 12 to 48 weeks, with a possibility for extended treatment (Continuation segment)

Conditions

  • Ligneous Conjunctivitis

Interventions

BIOLOGICAL

Human Plasminogen

Eye Drops

Sponsors & Collaborators

  • Kedrion S.p.A.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-22
Primary Completion
2014-04-25
Completion
2020-12-04

Countries

  • United States
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01554956 on ClinicalTrials.gov