The Effectiveness and Safety of FK-506 for the Treatment of Posner-Schlossman Syndrome
Peking University Third Hospital Medical Science Research Ethics Committee
1 other identifier
interventional
30
1 country
1
Brief Summary
To evaluate the effectiveness and safety of tacrolimus eye drops (FK-506) in the treatment of Posner-Schlossman Syndrome. It is expected to collect 30 patients with PSS who are in the Ophthalmology Department of Peking University Third Hospital. The included PSS patients were divided into experimental group and control group using simple randomization method. Among them, the experimental group was treated with FK-506 twice a day, and the control group was treated with prednisolone acetate ophthalmic suspension 1% 4 times a day. For all PSS patients whose intraocular pressure is higher than 30mmHg, also add brinzolamide eye drops 3 times a day. Best corrected visual acuity, Goldmann intraocular pressure, anterior section photographs, corneal endothelial cells，corneal confocal microscope, Heidelberg retinal nerve analysis, Octopus visual field were examined on baseline and 1 week, 2 weeks, 3 weeks, 4 weeks after the treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedAugust 16, 2021
August 1, 2021
10 months
September 14, 2020
August 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Silt-lamp examination of the cornea
KP numbers after the treatment
1 week after the treatment
Silt-lamp examination of the cornea
KP numbers after the treatment
2 weeks after the treatment
Silt-lamp examination of the cornea
KP numbers after the treatment
3 weeks after the treatment
Silt-lamp examination of the cornea
KP numbers after the treatment
4 weeks after the treatment
Secondary Outcomes (4)
Goldmann ophthalmotonometer examination of intra-ocular pressure
1 week after the treatment
Goldmann ophthalmotonometer examination of intra-ocular pressure
2 weeks after the treatment
Goldmann ophthalmotonometer examination of intra-ocular pressure
3 weeks after the treatment
Goldmann ophthalmotonometer examination of intra-ocular pressure
4 weeks after the treatment
Study Arms (2)
The experimental group
EXPERIMENTALThe control group
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- \- Clinical diagnosis of PSS Must be able to communicate with doctor and understand this study
You may not qualify if:
- \- Fuchs syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hosipital
Beijing, Beijing Municipality, 100191, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chun Zhang, PHD,MD
Peking University Third Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 14, 2020
First Posted
October 19, 2020
Study Start
October 1, 2020
Primary Completion
August 1, 2021
Study Completion
September 1, 2021
Last Updated
August 16, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share