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

August 13, 2021 updated by: Chun Zhang, Peking University

Peking University Third Hospital Medical Science Research Ethics Committee

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hosipital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Fuchs syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The experimental group
Drug: FK-506 (Drug)
Twice a day
Other Names:
  • Tacrolimus eye drops
Sham Comparator: The control group
Drug: Prednisolone Acetate 1% Oph Susp
Four times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Silt-lamp examination of the cornea
Time Frame: 1 week after the treatment
KP numbers after the treatment
1 week after the treatment
Silt-lamp examination of the cornea
Time Frame: 2 weeks after the treatment
KP numbers after the treatment
2 weeks after the treatment
Silt-lamp examination of the cornea
Time Frame: 3 weeks after the treatment
KP numbers after the treatment
3 weeks after the treatment
Silt-lamp examination of the cornea
Time Frame: 4 weeks after the treatment
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
Time Frame: 1 week after the treatment
change of intra-ocular pressure
1 week after the treatment
Goldmann ophthalmotonometer examination of intra-ocular pressure
Time Frame: 2 weeks after the treatment
change of intra-ocular pressure
2 weeks after the treatment
Goldmann ophthalmotonometer examination of intra-ocular pressure
Time Frame: 3 weeks after the treatment
change of intra-ocular pressure
3 weeks after the treatment
Goldmann ophthalmotonometer examination of intra-ocular pressure
Time Frame: 4 weeks after the treatment
change of intra-ocular pressure
4 weeks after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Investigators

  • Study Director: Chun Zhang, PHD,MD, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

October 11, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00006761-M2020059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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