Effect of Ciclosporin eyedrops on symptoms of the eye and visual quality in patients with dry eye syndrome and primary or secondary Sjögren syndrome

Effect of Ciclosporin eyedrops on ocular symptoms and optical image quality in patients with primary or secondary Sjögren syndrome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004929-33-AT

Enrollment

Registered

2018-11-27

Start date

2018-12-05

Completion date

Unknown

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary or secondary Sjögren Syndrome

Interventions

Trade Name: Ikervis Product Name: Ikervis Pharmaceutical Form: Eye drops, emulsion INN or Proposed INN: CICLOSPORIN CAS Number: 59865-13-3 Concentration unit: mg/ml milligram(s)/millilitre Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Diagnosis of severe keratoconjunctivitis sicca defined by: 1) Staining of the cornea = Grade III according to the Oxford scale 2) OSDI value = 12 - Age between 18 and 90 years - Primary or secondary Sjögren syndrome (defined according to the American-European Consensus Group criteria) - Stable course of the underlying rheumatic disease and unchanged systemic treatment for 6 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - Pregnancy - Children and adolescents up to the age of 18 - Eye surgery in the last 6 months - Simultaneous participation in another study - Regular use of eye drops except for tear substitutes - Use of Ciclosporin-containing or Corticosteroid-containing eye drops in the last 6 months

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to investigate the effect of Ciclosporin 1mg/ml eye drops (Ikervis, Santen) with Hydrocortison 3,35 mg/ml eyedrops in addition to intensively lubricating therapy on ocular symptoms and optical image quality for the treatment of patients with primary or secondary Sjögren syndrome.;Secondary Objective: not applicable;Primary end point(s): Difference of tear break-up time measured with Fluorescein (in seconds) between the screening-visit and after 2 weeks of treatment.;Timepoint(s) of evaluation of this end point: At the beginning of the study and 2 weeks, 1 month, 3 months and 6 months after the beginning the treatment period	—

Measure

Time frame

Main Objective: The objective of this study is to investigate the effect of Ciclosporin 1mg/ml eye drops (Ikervis, Santen) with Hydrocortison 3,35 mg/ml eyedrops in addition to intensively lubricating therapy on ocular symptoms and optical image quality for the treatment of patients with primary or secondary Sjögren syndrome.;Secondary Objective: not applicable;Primary end point(s): Difference of tear break-up time measured with Fluorescein (in seconds) between the screening-visit and after 2 weeks of treatment.;Timepoint(s) of evaluation of this end point: At the beginning of the study and 2 weeks, 1 month, 3 months and 6 months after the beginning the treatment period

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Secondary

Measure	Time frame
Secondary end point(s): - Difference of of tear break-up time measured with Fluorescein (in seconds) between the screening-visit and after 1 month, 3 months and 6 months of treatment. - Difference of the following parameters between the screening-visit and after 2 weeks, 1 month, 3 months and 6 months of treatment: * Corneal aberration values (RMS value, HORAS, Strehl ratio and MTF) * Failure rate of meibomian glands * Non-Invasive tear break-up time (in seconds) * Staining of the cornea with fluorescein (Oxford Grading) * Staining of the conjunctiva with Lissamingreen (Oxford Grading) * Tear secretion using Schirmer I test (in millimeters) * Ocular Surface Disease Index (OSDI) * Visual Analogue Scale (VAS);Timepoint(s) of evaluation of this end point: At the beginning of the study and 2 weeks 1 month, 3 months and 6 months after the beginning the treatment period	—

Measure

Time frame

Secondary end point(s): - Difference of of tear break-up time measured with Fluorescein (in seconds) between the screening-visit and after 1 month, 3 months and 6 months of treatment. - Difference of the following parameters between the screening-visit and after 2 weeks, 1 month, 3 months and 6 months of treatment: * Corneal aberration values (RMS value, HORAS, Strehl ratio and MTF) * Failure rate of meibomian glands * Non-Invasive tear break-up time (in seconds) * Staining of the cornea with fluorescein (Oxford Grading) * Staining of the conjunctiva with Lissamingreen (Oxford Grading) * Tear secretion using Schirmer I test (in millimeters) * Ocular Surface Disease Index (OSDI) * Visual Analogue Scale (VAS);Timepoint(s) of evaluation of this end point: At the beginning of the study and 2 weeks 1 month, 3 months and 6 months after the beginning the treatment period

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Countries

Austria

Contacts

Public ContactSecretary Office

KH Hietzing, Department of Ophthalmology

khr.aug@wienkav.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: May 22, 2026