The Effectiveness and Safety of FK-506 for the Treatment of Posner-Schlossman Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Peking University Third Hospital Medical Science Research Ethics Committee

Conditions
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Posner Schlossman Syndrome

Intervention / Treatment
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* Drug: FK-506 (Drug)
* Drug: Prednisolone Acetate 1% Oph Susp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Clinical diagnosis of PSS Must be able to communicate with doctor and understand this study Exclusion Criteria: - Fuchs syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The experimental group<br> | Drug: FK-506 (Drug)<br>* Twice a day<br>* Other names: Tacrolimus eye drops;|
| Sham Comparator: The control group<br> | Drug: Prednisolone Acetate 1% Oph Susp<br>* Four times a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Goldmann ophthalmotonometer examination of intra-ocular pressure | change of intra-ocular pressure | 1 week after the treatment | 
| Goldmann ophthalmotonometer examination of intra-ocular pressure | change of intra-ocular pressure | 2 weeks after the treatment | 
| Goldmann ophthalmotonometer examination of intra-ocular pressure | change of intra-ocular pressure | 3 weeks after the treatment | 
| Goldmann ophthalmotonometer examination of intra-ocular pressure | change of intra-ocular pressure | 4 weeks after the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posner Schlossman Syndrome, FK-506, effectiveness, safety