The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy

Dry Eye Syndrome Clinical Trial

Official title:

The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579539
• Other study ID #: OPHT-120312
• Status: Completed
• Phase: Phase 3
• Start date: June 27, 2013
• Est. completion date: May 18, 2017

Study information

• Verified date: February 2020
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Thyroid-associated ophthalmopathy (TAO), also called Graves' ophthalmopathy or thyroid eye disease, is a common orbital disease in adults. Patients with TAO, especially in its active phase, often complain about symptoms of ocular surface discomfort, including excess tearing, gritty sensation, increased sensitivity to light and foreign-body sensation, which are similar to inflammatory ocular surface disorders such as dry-eye syndrome (DES). Incomplete blink, increased proptosis and greater palpebral fissure width in TAO accelerates tear evaporation, which increases the tear fluid's osmolarity, and results in ocular surface damage. The administration of intravenous glucocorticoids can be an effective treatment for TAO.

The rationale of the present study is to assess the effect of intravenously administered glucocorticoids on the signs of DES in patients with TAO with new methods such as measurement of tear film thickness, tear film osmolarity and scattering of the tear film and well established methods for assessment of the severity of DES. Additionally, impression cytology and determination of tear cytokines/chemokines will be performed to obtain information about inflammatory processes on the ocular surface.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 18, 2017
• Est. primary completion date: May 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Chronic inactive TAO

• Previous treatment with oral or intravenous glucocorticoids 3 months preceding 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

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Eye Diseases
• Graves Ophthalmopathy
• Keratoconjunctivitis Sicca
• Thyroid Diseases
• Thyroid-associated Ophthalmopathy

Intervention

Drug:
• Methylprednisolone
500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. infusion once a week for 6 weeks
• Esomeprazole
40mg i.v. infusion once a week for 12 weeks

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear film thickness as measured with OCT	Measurements of tear film thickness with OCT will be performed 7 or less days before start of treatment, 6 weeks after start of treatment and 12 weeks after start of treatment	13 weeks
Secondary	Break up time (BUT)		13 weeks
Secondary	Visual acuity		13 weeks
Secondary	Tear film osmolarity		13 weeks
Secondary	Degree of exophthalmia	Hertel exophthalmometry	13 weeks
Secondary	Palpebral fissure width		13 weeks
Secondary	OSI (Objective Scattering Index)		13 weeks
Secondary	Tear cytokines/chemokines		13 weeks
Secondary	Impression cytology		13 weeks
Secondary	Staining of the cornea with fluorescein		13 weeks
Secondary	Schirmer I test		13 weeks
Secondary	Subjective symptoms of dry eye syndrome		13 weeks