Allogenic Plasma Aliquots in the Treatment of Ligneous Conjunctivitis

Study Overview
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Brief Summary
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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
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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

Official Title
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The Use of Allogenic Plasma Aliquots as a Source of Plasminogen in the Treatment of Ligneous Conjunctivitis, Clinical Trial of One Case

Conditions
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Ligneous Conjunctivitis, Left Eye

Intervention / Treatment
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* Biological: Allogenic plasma aliquots, a source of plasminogen


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The patient will receive treatment with the interventional biologic product when she experiences recurrences of ligneous conjunctivitis
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allogenic Plasma Aliquots<br>Allogenic Plasma Aliquots to be used as eye drops in the treatment of recurrences of ligneous conjunctivitis. Two drops will be administered to the affected eye, every 1 to 4 hours, depending on severity of the recurrence. | Biological: Allogenic plasma aliquots, a source of plasminogen<br>* Plasma eye drops, a source of plasminogen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of pseudo membrane associated with ligneous conjunctivitis | Patient to be observed daily to every few weeks for resolution, based on clinical observation | From date of first documented recurrence of pseudo membranes up to two years, starting from the date of enrolment |