Ligneous Conjunctivitis, Left EyePhase 3NCT04275232
Allogenic Plasma Aliquots in the Treatment of Ligneous Conjunctivitis
A Phase 3 study testing Allogenic plasma aliquots, a source of plasminogen in people with Ligneous Conjunctivitis, Left Eye, run by Dorothy Bautista, MD at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ligneous Conjunctivitis, Left Eye
- What is being tested?
- Allogenic plasma aliquots, a source of plasminogen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- May 2025to Oct 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subject diagnosed with ligneous conjunctivitis associated with Type 1 plasminogen deficiency
Who cannot join
- Subject has concurrent eye disease which prevents use of the investigational drug
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, A1B 3V6
About this study
Official title: The Use of Allogenic Plasma Aliquots as a Source of Plasminogen in the Treatment of Ligneous Conjunctivitis, Clinical Trial of One Case
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.
Read the 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
- Conditions
- Ligneous Conjunctivitis, Left Eye
- Being tested
- Allogenic plasma aliquots, a source of plasminogen
- Medical subject headings
- Plasminogen Deficiency, Type I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogenic plasma aliquots, a source of plasminogenBiological
Plasma eye drops, a source of plasminogen
| Study group | Role | What they receive |
|---|---|---|
| Allogenic Plasma Aliquots | Experimental | 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. Receives: Biological: Allogenic plasma aliquots, a source of plasminogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of pseudo membrane associated with ligneous conjunctivitis
Patient to be observed daily to every few weeks for resolution, based on clinical observation
Measured: From date of first documented recurrence of pseudo membranes up to two years, starting from the date of enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study startMay 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ligneous Conjunctivitis, Left EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The patient will receive treatment with the interventional biologic product when she experiences recurrences of ligneous conjunctivitis
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dorothy Bautista, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Blood Services
- Responsible party
- Sponsor-investigator, Dorothy Bautista, MD, Memorial University of Newfoundland
- Investigators
- Dorothy V Bautista, MD, Principal investigator, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275232
- Sponsor's protocol ID
- DVB-LC-1
- Status last verified
- Nov 2024
- First submitted
- 7 Feb 2020
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kizilocak H, Ozdemir N, Dikme G, Koc B, Atabek AA, Cokugras H, Iskeleli G, Donmez-Demir B, Christiansen NM, Ziegler M, Ozdag H, Schuster V, Celkan T. Treatment of plasminogen deficiency patients with fresh frozen plasma. Pediatr Blood Cancer. 2018 Feb;65(2). doi: 10.1002/pbc.26779. Epub 2017 Sep 6.
PubMed 28876531Ku JY, Lichtinger A, Yeung SN, Kim P, Cserti-Gazdewich C, Slomovic AR. Topical fresh frozen plasma and heparin treatment of ligneous conjunctivitis in a Canadian hospital setting. Can J Ophthalmol. 2012 Oct;47(5):e27-8. doi: 10.1016/j.jcjo.2012.03.025. Epub 2012 Jul 13. No abstract available.
PubMed 23036559Pergantou H, Likaki D, Fotopoulou M, Katsarou O, Xafaki P, Platokouki H. Management of ligneous conjunctivitis in a child with plasminogen deficiency. Eur J Pediatr. 2011 Oct;170(10):1333-6. doi: 10.1007/s00431-011-1483-9. Epub 2011 May 31.
PubMed 21625933Ang MJ, Papageorgiou KI, Chang SH, Kohn J, Chokron Garneau H, Goldberg RA. Topical Plasminogen as Adjunctive Treatment in Recurrent Ligneous Conjunctivitis. Ophthalmic Plast Reconstr Surg. 2017 Mar/Apr;33(2):e37-e39. doi: 10.1097/IOP.0000000000000694.
PubMed 27065432Shapiro AD, Nakar C, Parker JM, Albert GR, Moran JE, Thibaudeau K, Thukral N, Hardesty BM, Laurin P, Sandset PM. Plasminogen replacement therapy for the treatment of children and adults with congenital plasminogen deficiency. Blood. 2018 Mar 22;131(12):1301-1310. doi: 10.1182/blood-2017-09-806729. Epub 2018 Jan 10.
PubMed 29321155Conforti FM, Di Felice G, Bernaschi P, Bartuli A, Bianco G, Simonetti A, Buzzonetti L, Valente P, Corsetti T. Novel plasminogen and hyaluronate sodium eye drop formulation for a patient with ligneous conjunctivitis. Am J Health Syst Pharm. 2016 Apr 15;73(8):556-61. doi: 10.2146/ajhp150395.
PubMed 27045067
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Allogenic Plasma Aliquots as a Source of Plasminogen in the Treatment of Ligneous Conjunctivitis, Clinical Trial of One Case
- ClinicalTrials.gov ID
- NCT04275232
- Acronym / sponsor ID
- DVB-LC-1
- Conditions
- Ligneous Conjunctivitis, Left Eye
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Dorothy Bautista, MDUniversity, hospital or other
- Collaborators
- Canadian Blood Services
- Study start
- May 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The patient will receive treatment with the interventional biologic product when she experiences recurrences of ligneous conjunctivitis
| Arm | Type | Receives |
|---|---|---|
| Allogenic Plasma Aliquots | Experimental | Biological: Allogenic plasma aliquots, a source of plasminogenAllogenic 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 may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subject diagnosed with ligneous conjunctivitis associated with Type 1 plasminogen deficiency
Key exclusion criteria (1 listed)
- Subject has concurrent eye disease which prevents use of the investigational drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogenic plasma aliquots, a source of plasminogenPlasma eye drops, a source of plasminogen | Biological | Allogenic Plasma Aliquots |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Background: PubMed 28876531Kizilocak H, Ozdemir N, Dikme G, Koc B, Atabek AA, Cokugras H, Iskeleli G, Donmez-Demir B, Christiansen NM, Ziegler M, Ozdag H, Schuster V, Celkan T. Treatment of plasminogen deficiency patients with fresh frozen plasma. Pediatr Blood Cancer. 2018 Feb;65(2). doi: 10.1002/pbc.26779. Epub 2017 Sep 6.
- Background: PubMed 23036559Ku JY, Lichtinger A, Yeung SN, Kim P, Cserti-Gazdewich C, Slomovic AR. Topical fresh frozen plasma and heparin treatment of ligneous conjunctivitis in a Canadian hospital setting. Can J Ophthalmol. 2012 Oct;47(5):e27-8. doi: 10.1016/j.jcjo.2012.03.025. Epub 2012 Jul 13. No abstract available.
- Background: PubMed 21625933Pergantou H, Likaki D, Fotopoulou M, Katsarou O, Xafaki P, Platokouki H. Management of ligneous conjunctivitis in a child with plasminogen deficiency. Eur J Pediatr. 2011 Oct;170(10):1333-6. doi: 10.1007/s00431-011-1483-9. Epub 2011 May 31.
- Background: PubMed 27065432Ang MJ, Papageorgiou KI, Chang SH, Kohn J, Chokron Garneau H, Goldberg RA. Topical Plasminogen as Adjunctive Treatment in Recurrent Ligneous Conjunctivitis. Ophthalmic Plast Reconstr Surg. 2017 Mar/Apr;33(2):e37-e39. doi: 10.1097/IOP.0000000000000694.
- Background: PubMed 29321155Shapiro AD, Nakar C, Parker JM, Albert GR, Moran JE, Thibaudeau K, Thukral N, Hardesty BM, Laurin P, Sandset PM. Plasminogen replacement therapy for the treatment of children and adults with congenital plasminogen deficiency. Blood. 2018 Mar 22;131(12):1301-1310. doi: 10.1182/blood-2017-09-806729. Epub 2018 Jan 10.
- Background: PubMed 27045067Conforti FM, Di Felice G, Bernaschi P, Bartuli A, Bianco G, Simonetti A, Buzzonetti L, Valente P, Corsetti T. Novel plasminogen and hyaluronate sodium eye drop formulation for a patient with ligneous conjunctivitis. Am J Health Syst Pharm. 2016 Apr 15;73(8):556-61. doi: 10.2146/ajhp150395.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dorothy V Bautista, MD principal investigator
Memorial University of Newfoundland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Allogenic plasma aliquots, a source of plasminogen in people with Ligneous Conjunctivitis, Left Eye, run by Dorothy Bautista, MD at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04275232, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.