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

Posner Schlossman Syndrome Clinical Trial

Official title:

Peking University Third Hospital Medical Science Research Ethics Committee

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04590183
• Other study ID #: IRB00006761-M2020059
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 2021

Study information

• Verified date: August 2021
• Source: Peking University
• Contact: Tingting Gao, PHD
• Phone: 0086-13795176872
• Email: gaotingting8139[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of PSS Must be able to communicate with doctor and understand this study

Exclusion Criteria:

• Fuchs syndrome

Related Conditions & MeSH terms

• Posner Schlossman Syndrome
• Syndrome

Intervention

Drug:
• FK-506 (Drug)
Twice a day
• Prednisolone Acetate 1% Oph Susp
Four times a day

Locations

Country	Name	City	State
China	Peking University Third Hosipital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Silt-lamp examination of the cornea	KP numbers after the treatment	1 week after the treatment
Primary	Silt-lamp examination of the cornea	KP numbers after the treatment	2 weeks after the treatment
Primary	Silt-lamp examination of the cornea	KP numbers after the treatment	3 weeks after the treatment
Primary	Silt-lamp examination of the cornea	KP numbers after the treatment	4 weeks after the treatment
Secondary	Goldmann ophthalmotonometer examination of intra-ocular pressure	change of intra-ocular pressure	1 week after the treatment
Secondary	Goldmann ophthalmotonometer examination of intra-ocular pressure	change of intra-ocular pressure	2 weeks after the treatment
Secondary	Goldmann ophthalmotonometer examination of intra-ocular pressure	change of intra-ocular pressure	3 weeks after the treatment
Secondary	Goldmann ophthalmotonometer examination of intra-ocular pressure	change of intra-ocular pressure	4 weeks after the treatment