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Effect of Ciclosporin Eyedrops on Sjögren Syndrome

Primary Purpose

Dry Eye Syndromes

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Cyclosporin

Hydrocortisone

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of severe keratoconjunctivitis sicca defined by:
Staining of the cornea ≥ grade III according to the Oxford scale
OSDI value ≥ 12
Age between 18 and 90 years
Primary or secondary Sjogren's syndrome (defined according to the American-European Consensus Group criteria) with a stable course and unchanged treatment for 6 months

Exclusion criteria:

Pregnancy (excluded with a pregnancy test in patients of childbearing potential)
Children and young people up to the age of 18
Eye surgery in the past 6 months
Simultaneous participation in another study
Regular use of eye drops, with the exception of tear substitutes
Use of eye drops containing ciclosporin or glucocorticoids in the last 6 months

Sites / Locations

Augenabteilung - Klinik Hietzing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

right eye: Ciclosporin, left eye: Ciclosporin + Hydrocortisone

left eye: Ciclosporin, right eye: Ciclosporin + Hydrocortisone

Arm Description

Patients receive treatment with Ciclosporin eyedrops for the right eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the left eye

Patients receive treatment with Ciclosporin eyedrops for the left eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the right eye

Outcomes

Primary Outcome Measures

tearfilm breakup time

tearfilm breakup time measured with Fluorescein

corneal fluorescein staining

corneal fluorescein staining staged with Oxford grading scale, ranging from 0 (no staining) to 5 (maximal staining)

corneal optical aberrations

corneal optical aberrations measured with iTrace aberrometry

Secondary Outcome Measures

Full Information

NCT ID

NCT04597762

First Posted

October 16, 2020

Last Updated

April 6, 2021

Sponsor

Hospital Hietzing

1. Study Identification

Unique Protocol Identification Number

NCT04597762

Brief Title

Effect of Ciclosporin Eyedrops on Sjögren Syndrome

Official Title

Effect of Ciclosporin Eyedrops on Ocular Symptoms and Optical Quality in Patients With Sjögren Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

August 31, 2020 (Actual)

Primary Completion Date

March 30, 2021 (Actual)

Study Completion Date

March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Hietzing

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Keratoconjunctivitis sicca, also known as dry eye syndrome, is one of the most common ophthalmological diseases and is treated with tear substitutes to moisten the surface of the eye and, in more severe cases of this disease, with local anti-inflammatory therapy with corticosteroids or ciclosporin A. In patients with rheumatological diseases, such as Sjögren's syndrome, dry eye syndrome of severe extent occurs particularly frequently, which is why topical anti-inflammatory therapy is often necessary in these patients. Aim of this study is to evaluate the treatment of severe dry eye syndrome with topical cyclosporin eyedrops with and without topical corticosteroids at the beginning of the treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndromes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

right eye: Ciclosporin, left eye: Ciclosporin + Hydrocortisone

Arm Type

Experimental

Arm Description

Patients receive treatment with Ciclosporin eyedrops for the right eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the left eye

Arm Title

left eye: Ciclosporin, right eye: Ciclosporin + Hydrocortisone

Arm Type

Experimental

Arm Description

Patients receive treatment with Ciclosporin eyedrops for the left eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the right eye

Intervention Type

Drug

Intervention Name(s)

Cyclosporin

Intervention Description

Cyclosporin eyedrops

Intervention Type

Drug

Intervention Name(s)

Hydrocortisone

Intervention Description

Hydrocortisone eyedrops

Primary Outcome Measure Information:

Title

tearfilm breakup time

Description

tearfilm breakup time measured with Fluorescein

Time Frame

6 months

Title

corneal fluorescein staining

Description

corneal fluorescein staining staged with Oxford grading scale, ranging from 0 (no staining) to 5 (maximal staining)

Time Frame

6 months

Title

corneal optical aberrations

Description

corneal optical aberrations measured with iTrace aberrometry

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of severe keratoconjunctivitis sicca defined by: Staining of the cornea ≥ grade III according to the Oxford scale OSDI value ≥ 12 Age between 18 and 90 years Primary or secondary Sjogren's syndrome (defined according to the American-European Consensus Group criteria) with a stable course and unchanged treatment for 6 months Exclusion criteria: Pregnancy (excluded with a pregnancy test in patients of childbearing potential) Children and young people up to the age of 18 Eye surgery in the past 6 months Simultaneous participation in another study Regular use of eye drops, with the exception of tear substitutes Use of eye drops containing ciclosporin or glucocorticoids in the last 6 months

Facility Information:

Facility Name

Augenabteilung - Klinik Hietzing

City

Vienna

ZIP/Postal Code

1130

Country

Austria

12. IPD Sharing Statement

Plan to Share IPD

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Effect of Ciclosporin Eyedrops on Sjögren Syndrome

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