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Enrolling by Invitation

NCT Number: NCT04275232

Allogenic Plasma Aliquots in the Treatment of Ligneous Conjunctivitis

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.

Enrolling by Invitation

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Key information

Conditions

Ligneous Conjunctivitis, Left Eye Plasminogen Deficiency, Type I

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allogenic plasma aliquots, a source of plasminogen

Biological

Plasma eye drops, a source of plasminogen

Primary outcomes

  1. Resolution of pseudo membrane associated with ligneous conjunctivitis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Dorothy Bautista, MD

Other

Collaborators

  • Canadian Blood Services

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2020
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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