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

Sponsor
Peking University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04590183
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: FK-506 (Drug)
  • Drug: Prednisolone Acetate 1% Oph Susp
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Peking University Third Hospital Medical Science Research Ethics Committee
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Silt-lamp examination of the cornea [1 week after the treatment]

      KP numbers after the treatment

    2. Silt-lamp examination of the cornea [2 weeks after the treatment]

      KP numbers after the treatment

    3. Silt-lamp examination of the cornea [3 weeks after the treatment]

      KP numbers after the treatment

    4. Silt-lamp examination of the cornea [4 weeks after the treatment]

      KP numbers after the treatment

    Secondary Outcome Measures

    1. Goldmann ophthalmotonometer examination of intra-ocular pressure [1 week after the treatment]

      change of intra-ocular pressure

    2. Goldmann ophthalmotonometer examination of intra-ocular pressure [2 weeks after the treatment]

      change of intra-ocular pressure

    3. Goldmann ophthalmotonometer examination of intra-ocular pressure [3 weeks after the treatment]

      change of intra-ocular pressure

    4. Goldmann ophthalmotonometer examination of intra-ocular pressure [4 weeks after the treatment]

      change of intra-ocular pressure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Clinical diagnosis of PSS Must be able to communicate with doctor and understand this study
    Exclusion Criteria:
    • Fuchs syndrome

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Third Hosipital Beijing Beijing China 100191

    Sponsors and Collaborators

    • Peking University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chun Zhang, Professor, Peking University
    ClinicalTrials.gov Identifier:
    NCT04590183
    Other Study ID Numbers:
    • IRB00006761-M2020059
    First Posted:
    Oct 19, 2020
    Last Update Posted:
    Aug 16, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chun Zhang, Professor, Peking University
    Posner Schlossman Syndrome
    FK-506
    effectiveness
    safety
    Additional relevant MeSH terms:
    Syndrome
    Prednisolone
    Methylprednisolone Acetate
    Methylprednisolone
    Methylprednisolone Hemisuccinate
    Prednisolone acetate
    Tacrolimus
    Prednisolone hemisuccinate
    Prednisolone phosphate

    Study Results

    No Results Posted as of Aug 16, 2021