NCT05294666

Brief Summary

It is planned to explore the efficacy and safety of local 0.05% cyclosporine eye drops in the treatment of chronic graft-versus-host eye disease. Through the comparative study with 0.1% tacrolimus eye drops, to clarify the short-term and long-term efficacy of 0.05% CSA in these patients, and to explore the benefits of long-term maintenance of local cyclosporine to patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
Last Updated

March 24, 2022

Status Verified

January 1, 2022

Enrollment Period

1.2 years

First QC Date

February 7, 2022

Last Update Submit

March 14, 2022

Conditions

Graft Versus Host Disease in Eye

Keywords

ocular graft-versus-host diseasedry eyecyclosporinetacrolimusprospective study

Outcome Measures

Primary Outcomes (20)

  • visual acuity

    visual acuity

    Within 4 hours of initial enrollment

  • visual acuity

    visual acuity

    At the first month of enrollment

  • visual acuity

    visual acuity

    At the third month of enrollment

  • visual acuity

    visual acuity

    At the sixth month of enrollment

  • Intraocular pressure

    Intraocular pressure

    Within 4 hours of initial enrollment

  • Intraocular pressure

    Intraocular pressure

    At the first month of enrollment

  • Intraocular pressure

    Intraocular pressure

    At the third month of enrollment

  • Intraocular pressure

    Intraocular pressure

    At the sixth month of enrollment

  • Ocular Surface Disease Index

    Ocular Surface Disease Index

    Within 4 hours of initial enrollment

  • Ocular Surface Disease Index

    Ocular Surface Disease Index

    At the first month of enrollment

  • Ocular Surface Disease Index

    Ocular Surface Disease Index

    At the third month of enrollment

  • Ocular Surface Disease Index

    Ocular Surface Disease Index

    At the sixth month of enrollment

  • Corneal fluorescein staining

    Corneal fluorescein staining

    Within 4 hours of initial enrollment

  • Corneal fluorescein staining

    Corneal fluorescein staining

    At the first month of enrollment

  • Corneal fluorescein staining

    Corneal fluorescein staining

    At the third month of enrollment

  • Corneal fluorescein staining

    Corneal fluorescein staining

    At the sixth month of enrollment

  • Tear break-up time

    Tear break-up time

    Within 4 hours of initial enrollment

  • Tear break-up time

    Tear break-up time

    At the first month of enrollment

  • Tear break-up time

    Tear break-up time

    At the third month of enrollment

  • Tear break-up time

    Tear break-up time

    At the sixth month of enrollment

Study Arms (2)

cyclosporine group

EXPERIMENTAL

The chronic ocular GVHD patients in cyclosporine group received local 0.05% cyclosporine 4 times/day for 3 months, and then changed to 0.05% cyclosporine for 2 times/day for 3 months

Drug: Cyclosporine

tacrolimus group

EXPERIMENTAL

The chronic ocular GVHD patients in tacrolimus group received local 0.05% tacrolimus 2 times/day for 3 months, and then changed to 0.05% cyclosporine for 2 times/day for 3 months

Drug: tacrolimus

Interventions

CyclosporineDRUG

The chronic ocular GVHD patients in cyclosporine group received local 0.05% cyclosporine 4 times/day for 3 months, and then changed to 0.05% cyclosporine for 2 times/day for 3 months

Also known as: CsA
cyclosporine group
tacrolimusDRUG

The chronic ocular GVHD patients in tacrolimus group received local 0.05% tacrolimus 2 times/day for 3 months, and then changed to 0.05% cyclosporine for 2 times/day for 3 months

Also known as: FK506
tacrolimus group

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed as chronic ocular GVHD
  • Did not receive eye local immunosuppressive therapy
  • Non pregnant patients

You may not qualify if:

  • Have a history of eye surgery in the past six months
  • Suffering from other eye diseases (autoimmune diseases, glaucoma, serious infection, retinopathy, allergy, cataract, eye trauma, etc.)
  • Hormones or immunosuppressants were used before enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

CyclosporineTacrolimus

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsMacrolidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2022

First Posted

March 24, 2022

Study Start

April 1, 2020

Primary Completion

June 1, 2021

Study Completion

July 1, 2021

Last Updated

March 24, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)