The effect of intravenous glucocorticoids on the tearfilm in eyes with thyroid-associated ophthalmopathy

The effect of intravenous glucocorticoids on the tearfilm in eyes with thyroid-associated ophthalmopathy - Tearfilm in eyes with TAO

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001910-40-AT

Enrollment

Registered

2012-04-30

Start date

2012-06-06

Completion date

Unknown

Last updated

2018-08-20

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

Conditions

Thyroid-associated ophthalmopathy (TAO) MedDRA version: 14.1 Level: LLT Classification code 10065624 Term: Graves-Basedow disease System Organ Class: 10014698 - Endocrine disorders

Interventions

Trade Name: Urbason solubile 250 mg-Trockenampullen mit Lösungsmittel Product Name: Urbason solubile 250 mg Product Code: 0147507 Pharmaceutical Form: Powder and solvent for solution for infusion INN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Men and women aged over 18 years - Active thyroid associated ophthalmopathy with clinical activity score (CAS) of each eye more than 3 or recently experienced worsening of proptosis, lid retraction, or ocular motility disturbance. - Normal ophthalmic findings except symptoms associated with TAO - Scheduled for treatment with systemic glucocorticoids according to the kahaly-scheme 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: - Chronic inactive TAO - Previous treatment with oral or intravenous glucocorticoids 3 months preceeding the study - Participation in a clinical trial in the 3 weeks before the screening visit - Symptoms of a clinically relevant illness in the 3 weeks before the first study day - Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator - Wearing of contact lenses - Intake of dietary supplements in the 3 months preceding the study - Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants - Ocular infection - Ocular surgery in the 3 months preceding the study - Sjögren’s syndrome - Stevens-Johnson syndrome - Pregnancy, planned pregnancy or lactating

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the change in tear film thickness in eyes with thyroid-associated ophthalmopathy treated with intravenous glucocorticoids;Secondary Objective: Break up time (BUT) Visual Acuity Tear film osmolarity Degree of exophthalmia Palpebral fissure width OSI (Objective Scattering Index) Impression cytology Tear cytokines/chemokines Staining of the cornea with fluorescein Schirmer I test Subjective symptoms of dry eye syndrome ;Primary end point(s): Efficacy;Timepoint(s) of evaluation of this end point: after 6- and 12-weeks-treatment	—

Measure

Time frame

Main Objective: To assess the change in tear film thickness in eyes with thyroid-associated ophthalmopathy treated with intravenous glucocorticoids;Secondary Objective: Break up time (BUT) Visual Acuity Tear film osmolarity Degree of exophthalmia Palpebral fissure width OSI (Objective Scattering Index) Impression cytology Tear cytokines/chemokines Staining of the cornea with fluorescein Schirmer I test Subjective symptoms of dry eye syndrome ;Primary end point(s): Efficacy;Timepoint(s) of evaluation of this end point: after 6- and 12-weeks-treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Tolerability;Timepoint(s) of evaluation of this end point: after 6- and 12-weeks-treatment	—

Countries

Austria

Contacts

Public ContactUniv. Klinik f. Klin. Pharmakologie

Medizinische Universität Wien

klin-pharmakologie@meduniwien.ac.at+431404002981

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026