Back to resultsThe Effectiveness and Safety of FK-506 for the Treatment of Posner-Schlossman Syndrome
Primary Purpose
Posner Schlossman Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
FK-506 (Drug)
Prednisolone Acetate 1% Oph Susp
Sponsored by
About this trial
This is an interventional treatment trial for Posner Schlossman Syndrome focused on measuring Posner Schlossman Syndrome, FK-506, effectiveness, safety
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of PSS Must be able to communicate with doctor and understand this study
Exclusion Criteria:
- Fuchs syndrome
Sites / Locations
- Peking University Third HosipitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
The experimental group
The control group
Arm Description
Outcomes
Primary Outcome Measures
Silt-lamp examination of the cornea
KP numbers after the treatment
Silt-lamp examination of the cornea
KP numbers after the treatment
Silt-lamp examination of the cornea
KP numbers after the treatment
Silt-lamp examination of the cornea
KP numbers after the treatment
Secondary Outcome Measures
Goldmann ophthalmotonometer examination of intra-ocular pressure
change of intra-ocular pressure
Goldmann ophthalmotonometer examination of intra-ocular pressure
change of intra-ocular pressure
Goldmann ophthalmotonometer examination of intra-ocular pressure
change of intra-ocular pressure
Goldmann ophthalmotonometer examination of intra-ocular pressure
change of intra-ocular pressure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04590183
Brief Title
The Effectiveness and Safety of FK-506 for the Treatment of Posner-Schlossman Syndrome
Official Title
Peking University Third Hospital Medical Science Research Ethics Committee
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posner Schlossman Syndrome
Keywords
Posner Schlossman Syndrome, FK-506, effectiveness, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The experimental group
Arm Type
Experimental
Arm Title
The control group
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
FK-506 (Drug)
Other Intervention Name(s)
Tacrolimus eye drops
Intervention Description
Twice a day
Intervention Type
Drug
Intervention Name(s)
Prednisolone Acetate 1% Oph Susp
Intervention Description
Four times a day
Primary Outcome Measure Information:
Title
Silt-lamp examination of the cornea
Description
KP numbers after the treatment
Time Frame
1 week after the treatment
Title
Silt-lamp examination of the cornea
Description
KP numbers after the treatment
Time Frame
2 weeks after the treatment
Title
Silt-lamp examination of the cornea
Description
KP numbers after the treatment
Time Frame
3 weeks after the treatment
Title
Silt-lamp examination of the cornea
Description
KP numbers after the treatment
Time Frame
4 weeks after the treatment
Secondary Outcome Measure Information:
Title
Goldmann ophthalmotonometer examination of intra-ocular pressure
Description
change of intra-ocular pressure
Time Frame
1 week after the treatment
Title
Goldmann ophthalmotonometer examination of intra-ocular pressure
Description
change of intra-ocular pressure
Time Frame
2 weeks after the treatment
Title
Goldmann ophthalmotonometer examination of intra-ocular pressure
Description
change of intra-ocular pressure
Time Frame
3 weeks after the treatment
Title
Goldmann ophthalmotonometer examination of intra-ocular pressure
Description
change of intra-ocular pressure
Time Frame
4 weeks after the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of PSS Must be able to communicate with doctor and understand this study
Exclusion Criteria:
- Fuchs syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tingting Gao, PHD
Phone
0086-13795176872
Email
gaotingting8139@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun Zhang, PHD,MD
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Third Hosipital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pro. Zhang, PHD, MD
Phone
0086-186-0103-1059
Email
zhangc1@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effectiveness and Safety of FK-506 for the Treatment of Posner-Schlossman Syndrome
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