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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ocular involvement (Ligneous Conjunctivitis) due to plasminogen deficiency
Diagnosis of plasminogen deficiency (clinical presence of pseudomembranous lesions and serum plasminogen level < 50%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial will help us to determine whether plasminogen concentrate is an effective and safe treatment for patients with ligneous conjunctivitis.
Who is the study for?
This trial is for children under 18 with Ligneous Conjunctivitis, a type of pink eye caused by plasminogen deficiency. They must have pseudomembranous lesions and low serum plasminogen levels (<50%). It's not for adults or those without this specific condition.Check my eligibility
What is being tested?
The study tests the use of donor plasma applied directly to the eyes of kids with Ligneous Conjunctivitis. The treatment lasts 2-6 months based on how severe the disease is and how well the patient responds, with possible re-treatment if symptoms return.See study design
What are the potential side effects?
While specific side effects are not listed, serious adverse events related to plasma application in eyes will be monitored closely and reported to Canadian Blood Services and Health Canada.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have eye inflammation due to low plasminogen levels.
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I have been diagnosed with plasminogen deficiency.
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I am under 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in the visual acuity of affected eye after topical administration of aliquoted allogenic plasma into affected conjunctiva.
Plasma Proteins
Number of participants with development of strabismus or other visual defects in affected eye
+1 moreSecondary outcome measures
Number of participants with recurrence of pseudomembranous lesions
Time to development of recurrence of pseudomembranous lesions in the eye undergoing intervention.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention arm (aliquoted plasma application into the conjunctiva)Experimental Treatment1 Intervention
This is the only arm of the study. The intervention is administration of aliquoted plasma provided by Canadian Blood Services in eye droppers (3 ml aliquots in 7 ml vials) in the patient's conjunctiva.
The duration of therapy can be 2 to 6 months depending on response The intra-ocular drops will be administered every 1-5 hours daily in the affected eye based on disease severity and may be repeated
Find a Location
Who is running the clinical trial?
University of SaskatchewanLead Sponsor
251 Previous Clinical Trials
154,409 Total Patients Enrolled
Canadian Blood ServicesOTHER
20 Previous Clinical Trials
20,638 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a plasminogen deficiency.I do not have eye symptoms due to plasminogen deficiency.I am 18 years old or older.I have eye inflammation due to low plasminogen levels.I have been diagnosed with plasminogen deficiency.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention arm (aliquoted plasma application into the conjunctiva)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment accommodate individuals aged more than 25?
"In order to be a part of this research, potential participants must range from 1 Month old to 18 years in age. There are 8 studies for minors and 18 specifically designed for seniors."
Answered by AI
Are there any open slots in this trial for new participants?
"According to clinicaltrials.gov, the recruiting period for this medical trial has closed; although it was initially listed on November 15th 2022 and updated lastly on November 7th 2022. Fortunately, there are 22 other active studies that require participants at present."
Answered by AI
Do I meet the requirements to join this clinical research trial?
"This clinical trial is recruiting one individual with conjunctivitis between the ages of 1 month and 18 years. In order to be eligible, candidates must display symptoms such as pseudomembranous lesions and have a serum plasminogen level under 50%, alongside ocular involvement (in this case Ligneous Conjunctivitis) attributed to their plasminogen deficiency."
Answered by AI
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