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Clinical Trial Summary

The study evaluates the efficacy and safety of allogeneic platelet lysate eye drops in patients with severe ocular graft versus host disease refractory to conventional systemic and local treatments. The corneal staining, conjunctival hyperemia, tear film break up time,Schirmer test and ocular surface disease index will be evaluated before and after allogeneic platelet lysate treatment. The safety of allogeneic platelet lysate treatment will be also assessed.


Clinical Trial Description

The corneal staining with fluorescein will be assessed using Oxford grading scale. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05311514
Study type Interventional
Source St. Petersburg State Pavlov Medical University
Contact Natalya V Chistyakova, PhD
Phone +79217558218
Email nchistik@mail.ru
Status Recruiting
Phase Phase 2
Start date April 1, 2021
Completion date April 1, 2024

See also
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Active, not recruiting NCT04769648 - Safety and Efficacy of Pro-ocularâ„¢ 1% in Daily Scleral Lens Wearing Patients With Ocular Graft-versus-Host Disease Phase 2/Phase 3