← Back to Search

Plasma

Allogenic Plasma Eye Drops for Ligneous Conjunctivitis

Phase 3

Waitlist Available

Led By Dorothy V Bautista, MD

Research Sponsored by Dorothy Bautista, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject diagnosed with ligneous conjunctivitis associated with Type 1 plasminogen deficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of first documented recurrence of pseudo membranes up to two years, starting from the date of enrolment

Awards & highlights

Study Summary

This trial will test whether allogenic plasma aliquots, used as eye drops, can provide a source of plasminogen in the treatment of ligneous conjunctivitis. If successful, the product will be available by request from the Sponsor-Investigator to Canadian Blood Services, as approved by Health Canada.

Who is the study for?

This trial is for individuals diagnosed with ligneous conjunctivitis, a rare eye condition, who have Type 1 plasminogen deficiency. It's not suitable for those with other concurrent eye diseases that would interfere with the treatment.Check my eligibility

What is being tested?

The trial tests allogenic plasma aliquots used as eye drops to provide plasminogen in treating ligneous conjunctivitis. The plasma is obtained through Canadian Blood Services following Health Canada's approval.See study design

What are the potential side effects?

Potential side effects may include discomfort or irritation at the site of application, allergic reactions to plasma components, and possible infection risk due to the use of blood products.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with a rare eye condition due to a specific protein deficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of first documented recurrence of pseudo membranes up to two years, starting from the date of enrolment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of first documented recurrence of pseudo membranes up to two years, starting from the date of enrolment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first documented recurrence of pseudo membranes up to two years, starting from the date of enrolment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Resolution of pseudo membrane associated with ligneous conjunctivitis

Trial Design

1Treatment groups

Experimental Treatment

Group I: Allogenic Plasma AliquotsExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dorothy Bautista, MDLead Sponsor

Canadian Blood ServicesOTHER

20 Previous Clinical Trials

20,638 Total Patients Enrolled

Dorothy V Bautista, MDPrincipal InvestigatorMemorial University of Newfoundland

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to sign up for this experiment right now?

"Unfortunately, this particular trial is not taking any more patients at the moment. This is according to the clinicaltrials.gov website where the study was originally posted on May 1st 2023 and last edited on April 5th 2022. However, there are 27 other trials that are currently recruiting patients right now."

Answered by AI

What other medical research has been conducted using Allogenic plasma aliquots as a plasminogen source?

"There are 4 ongoing clinical trials for Allogenic plasma aliquots, a source of plasminogen. Out of those 4, 2 have reached Phase 3. Though the majority of studies testing this treatment method are based in Saskatoon and Île De France, there are 111 total research sites worldwide."

Answered by AI

Have other clinics tried anything like this before?

"There are 4 ongoing studies, as of now, for Allogenic plasma aliquots in 9 countries and 61 cities. The first study was performed in 2017 by Medtronic. That original trial had 410 patients and completed its N/A drug approval stage. In the years since the initial study, 6 more trials have completed."

Answered by AI

How risky is it for patients to receive Allogenic plasma aliquots, a source of plasminogen?

"Allogenic plasma aliquots, a plasminogen source, is backed by some efficacy data and multiple rounds of safety testing, so it received a score of 3."

Answered by AI

How many individuals are participating in this clinical experiment?

"Right now, this study is not looking for any more patients. The listing for the clinical trial was first put up on May 1st, 2023 and edited most recently on April 5th, 2022. If you're interested in other studies, there are 23 trials currently enrolling patients with conjunctivitis and 4 different trials involving allogenic plasma aliquots (a source of plasminogen) that are also still recruiting participants."

Answered by AI

Recent research and studies

Ophthalmic Plastic & Reconstructive SurgeryJournal

Topical Plasminogen as Adjunctive Treatment in Recurrent Ligneous Conjunctivitis

Ang, Michael J., Konstantinos I. Papageorgiou, Shu-Hong Chang, Jocelyn Kohn, Helen Chokron Garneau, and Robert A. Goldberg. 2017. “Topical Plasminogen as Adjunctive Treatment in Recurrent Ligneous Conjunctivitis”. Ophthalmic Plastic & Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/iop.0000000000000694.

American Journal of Health-System PharmacyJournal

Novel Plasminogen and Hyaluronate Sodium Eye Drop Formulation for a Patient with Ligneous Conjunctivitis

Conforti, Franca Manganelli, Giovina Di Felice, Paola Bernaschi, Andrea Bartuli, Giuseppe Bianco, Alessandra Simonetti, Luca Buzzonetti, Paola Valente, and Tiziana Corsetti. 2016. “Novel Plasminogen and Hyaluronate Sodium Eye Drop Formulation for a Patient with Ligneous Conjunctivitis”. American Journal of Health-system Pharmacy. Oxford University Press (OUP). doi:10.2146/ajhp150395.

Pediatric Blood & CancerJournal

Treatment of Plasminogen Deficiency Patients with Fresh Frozen Plasma

Kızılocak, Hande, Nihal Ozdemir, Gürcan Dikme, Begüm Koç, Ayşe Ayzıt Atabek, Haluk Çokuğraş, Güzin İskeleli, et al.. 2017. “Treatment of Plasminogen Deficiency Patients with Fresh Frozen Plasma”. Pediatric Blood & Cancer. Wiley. doi:10.1002/pbc.26779.

BloodJournal