Allogenic Plasma Aliquots in the Treatment of Ligneous Conjunctivitis
- Conditions
- Ligneous Conjunctivitis, Left Eye
- Interventions
- Biological: Allogenic plasma aliquots, a source of plasminogen
- Registration Number
- NCT04275232
- Lead Sponsor
- Dorothy Bautista, MD
- 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
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 1
- Subject diagnosed with ligneous conjunctivitis associated with Type 1 plasminogen deficiency
- Subject has concurrent eye disease which prevents use of the investigational drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Allogenic Plasma Aliquots Allogenic plasma aliquots, a source of plasminogen 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Memorial University of Newfoundland
🇨🇦St. John's, Newfoundland and Labrador, Canada