A Phase 3 interventional study of Allogenic plasma aliquots, a source of plasminogen in Ligneous Conjunctivitis, Left Eye, sponsored by Dorothy Bautista, MD. Enrolling by invitation at 1 site in Canada. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by Dorothy Bautista, MD · Phase 3, Interventional, and Treatment
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.
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
This is the only study on the registry with Dorothy Bautista, MD as lead sponsor.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Plasma eye drops, a source of plasminogen
Resolution of pseudo membrane associated with ligneous conjunctivitis
Patient to be observed daily to every few weeks for resolution, based on clinical observation
Time frame: From date of first documented recurrence of pseudo membranes up to two years, starting from the date of enrolment
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Plasminogen Deficiency, Type I