NCT04597762

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

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

August 31, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

October 16, 2020

Last Update Submit

April 6, 2021

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (3)

  • tearfilm breakup time

    tearfilm breakup time measured with Fluorescein

    6 months

  • corneal fluorescein staining

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

    6 months

  • corneal optical aberrations

    corneal optical aberrations measured with iTrace aberrometry

    6 months

Study Arms (2)

right eye: Ciclosporin, left eye: Ciclosporin + Hydrocortisone

EXPERIMENTAL

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

Drug: CyclosporinDrug: Hydrocortisone

left eye: Ciclosporin, right eye: Ciclosporin + Hydrocortisone

EXPERIMENTAL

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

Drug: CyclosporinDrug: Hydrocortisone

Interventions

CyclosporinDRUG

Cyclosporin eyedrops

left eye: Ciclosporin, right eye: Ciclosporin + Hydrocortisoneright eye: Ciclosporin, left eye: Ciclosporin + Hydrocortisone
HydrocortisoneDRUG

Hydrocortisone eyedrops

left eye: Ciclosporin, right eye: Ciclosporin + Hydrocortisoneright eye: Ciclosporin, left eye: Ciclosporin + Hydrocortisone

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augenabteilung - Klinik Hietzing

Vienna, 1130, Austria

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

CyclosporineHydrocortisone

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsPregnenedionesPregnenesPregnanesSteroidsFused-Ring Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pro. Dr. Pia Vécsei-Marlovits

Study Record Dates

First Submitted

October 16, 2020

First Posted

October 22, 2020

Study Start

August 31, 2020

Primary Completion

March 30, 2021

Study Completion

March 31, 2021

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)