Ligneous Conjunctivitis, Left Eye
Conditions
Brief summary
Allogenic plasma aliquots, used as eye drops, will provide a source of plasminogen in the treatment of ligneous conjunctivitis. The investigational product will be available through written request from the Sponsor-Investigator to Canadian Blood Services, as approved by Health Canada.
Detailed description
Ligneous conjunctivitis is a chronic progressive disorder of the conjunctival mucosa which occurs secondary to plasminogen deficiency. The condition is characterized by thick, fibrous pseudo membranes adherent to the conjunctival surface of the eye lid.The investigational product, allogenic plasma aliquots, is a source of plasminogen. It will be used as eye drops, to treat recurrences of these pseudo membranes by providing the plasminogen required for fibrinolysis. The allogenic plasma aliquots are prepared by Canadian Blood Services. An initial supply of 680 vials was made available through the Special Access program, upon approval by Health Canada. Through this Clinical Trial, additional allogenic plasma aliquots will be available when required to treat recurrences of the pseudo membranes. The study has been conditionally approved by local HREB, pending registration with clinicaltrials.gov
Interventions
BIOLOGICALAllogenic plasma aliquots, a source of plasminogen
Plasma eye drops, a source of plasminogen
Sponsors
Canadian Blood Services
Dorothy Bautista, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The patient will receive treatment with the interventional biologic product when she experiences recurrences of ligneous conjunctivitis
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Subject diagnosed with ligneous conjunctivitis associated with Type 1 plasminogen deficiency
Exclusion criteria
* Subject has concurrent eye disease which prevents use of the investigational drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of pseudo membrane associated with ligneous conjunctivitis | From date of first documented recurrence of pseudo membranes up to two years, starting from the date of enrolment | Patient to be observed daily to every few weeks for resolution, based on clinical observation |
Countries
Canada
Outcome results
None listed