Allogenic Plasma Eye Drops for Ligneous Conjunctivitis

Age: Any Age

Sex: Female

Trial Phase: Phase 3

Sponsor: Dorothy Bautista, MD

Disqualifiers: Concurrent eye disease

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Allogenic Plasma Aliquots for ligneous conjunctivitis?

Research shows that using fresh frozen plasma, which is similar to allogenic plasma, can prevent the recurrence of ligneous conjunctivitis and improve symptoms after eye surgeries. This suggests that allogenic plasma eye drops might also be effective for this condition. ^{1 2 3 4 5}

Is it safe to use allogenic plasma eye drops for ligneous conjunctivitis?

The use of fresh frozen plasma (a type of allogenic plasma) as eye drops has been reported in several cases for treating ligneous conjunctivitis, and no safety issues were highlighted in these reports. ^{1 2 4 5 6}

How does the treatment Allogenic Plasma Aliquots differ from other treatments for ligneous conjunctivitis?

Allogenic Plasma Aliquots, used as eye drops, are unique because they involve using plasma from donors to treat ligneous conjunctivitis, a rare eye condition. This approach is different from other treatments like heterologous serum or fresh frozen plasma, as it specifically uses plasma components to potentially address the underlying issues related to the condition. ^{1 2 3 4 7}

What is the purpose of this trial?

This trial uses eye drops made from donated blood plasma to treat patients with a rare eye condition called ligneous conjunctivitis. The eye drops provide a missing protein that helps dissolve harmful build-up on the eyes.

Research Team

Dorothy V Bautista, MD

Principal Investigator

Memorial University of Newfoundland

Eligibility Criteria

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.

Inclusion Criteria

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

Exclusion Criteria

I have an eye condition that prevents me from using certain medications.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive allogenic plasma aliquots as eye drops to treat recurrences of ligneous conjunctivitis

Up to 2 years

Daily to every few weeks, depending on severity

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Allogenic Plasma Aliquots

Trial Overview 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.

Participant Groups

Group I: Allogenic Plasma Aliquots Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Dorothy Bautista, MD

Lead Sponsor

Trials

1

Recruited

1+

Canadian Blood Services

Collaborator

Trials

24

Recruited

39,200+

References

1. United States pubmed.ncbi.nlm.nih.gov

Prevention of ligneous conjunctivitis by topical and subconjunctival fresh frozen plasma. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Anterior Segment Surgeries Under Topical Fresh Frozen Plasma Treatment in Ligneous Conjunctivitis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Adult-Onset Ligneous Conjunctivitis with Detection of a Novel Plasminogen Gene Mutation and Anti-Plasminogen IgA Antibody: A Clinicopathologic Study and Review of Literature. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Systemic and topical fresh-frozen plasma treatment in a newborn with ligneous conjunctivitis. [2009]

5. England pubmed.ncbi.nlm.nih.gov

Novel plasminogen and hyaluronate sodium eye drop formulation for a patient with ligneous conjunctivitis. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Tranexamic acid-associated ligneous conjunctivitis with gingival and peritoneal lesions. [2019]

7. Brazil pubmed.ncbi.nlm.nih.gov

Treatment of ligneous conjunctivitis with heterologous serum. [2020]