Allogeneic Platelet Lysate Eye Drops for the Treatment of Severe Chronic Ocular Graft-versus-host Disease
NCT ID: NCT05311514
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
38 participants
INTERVENTIONAL
2021-04-01
2024-11-29
Brief Summary
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Detailed Description
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Tear film break up time is the time in seconds taken to appear first dry sport after complete blinking. Fluorescein is instilled into the patient tear film, the tear film is observed under cobalt blue illumination.Schirmer test will be performed without anesthesia. Conjunctival hyperemia will be graded from 0 to 2. The OSDI questinnaire will assess the impact of treatment on the quality of life.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Allogeneic Platelet Lysate eye drops 50%
Patients with ocular chronic severe graft versus host disease receive 50% allogeneic Platelet Lysate in the form of eye drops 6-8 times a day
Allogeneic platelet lysate eye drops
Eye drops
Allogeneic Platelet Lysate eye drops 20%
Patients with ocular chronic severe graft versus host disease receive 20% allogeneic Platelet Lysate in the form of eye drops 6-8 times a day
Allogeneic platelet lysate eye drops
Eye drops
Interventions
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Allogeneic platelet lysate eye drops
Eye drops
Eligibility Criteria
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Inclusion Criteria
* Schirmer test \< 5mm\\5min
* Tear Film Break-up Time \< 5sec
* Corneal staining \> II Gr (Oxford grading scale)
* Ocular Surface Disease Index (OSDI) \>30
* Resistance to conventional therapy
Exclusion Criteria
* Other concomitant conditions, which does not allow to adequately assess the condition of the eye surface;
* Acute bacterial, viral or fungal infection of the eyes at the time of screening;
* Somatic or mental pathology that does not allow you to sign an informed consent;
* Keratoconjunctivitis sicca associated with an anomaly of the eyelids.
18 Years
75 Years
ALL
No
Sponsors
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St. Petersburg State Pavlov Medical University
OTHER
Responsible Party
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Ivan S Moiseev
Vice-director for science RM Gorbacheva Institute
Locations
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First Pavlov State Medical University of St. Petersburg
Saint Petersburg, , Russia
Countries
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Other Identifiers
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15/21-n
Identifier Type: -
Identifier Source: org_study_id