Trials / Completed
CompletedNCT01554956
Efficacy/Safety of Human Plasminogen Eye Drop in Ligneous Conjunctivitis Patients
A Historically Controlled Phase II/III Study to Evaluate Efficacy and Safety of Kedrion Human Plasminogen Eye Drop Preparation in Patients Diagnosed With Ligneous Conjunctivitis
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Kedrion S.p.A. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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)
Detailed description
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). The study will be divided into 3 segments: segments 1 and 2 for assessment of efficacy and safety and segment 3 (continuation segment) assessing long-term safety. For each enrolled patient, both eyes will be treated regardless of unilateral or bilateral involvement. Treatment of the unaffected eyes provided data for the safety assessment. To assess efficacy, comparisons will be made against individual patient historical data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Human Plasminogen | Eye Drops |
Timeline
- Start date
- 2013-05-22
- Primary completion
- 2014-04-25
- Completion
- 2020-12-04
- First posted
- 2012-03-15
- Last updated
- 2023-01-25
- Results posted
- 2023-01-25
Locations
3 sites across 2 countries: United States, Italy
Source: ClinicalTrials.gov record NCT01554956. Inclusion in this directory is not an endorsement.