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

Phase 1

• Conditions: Thyroid-associated ophthalmopathy (TAO); MedDRA version: 14.1Level: LLTClassification code 10065624Term: Graves-Basedow diseaseSystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-001910-40-AT
• Lead Sponsor: Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-30
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified