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

NCT ID: NCT01579539

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-27
• Study Completion Date: 2017-05-18

Brief 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.

Conditions

Thyroid-associated Ophthalmopathy; Dry Eye Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients

Patients with moderate to severe thyroid-associated ophthalmopathy

Group Type: EXPERIMENTAL

Methylprednisolone

Intervention Type: DRUG

500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. infusion once a week for 6 weeks

Esomeprazole

Intervention Type: DRUG

40mg i.v. infusion once a week for 12 weeks

Interventions

Methylprednisolone

500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. infusion once a week for 6 weeks

Intervention Type: DRUG

Esomeprazole

40mg i.v. infusion once a week for 12 weeks

Intervention Type: DRUG

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Gerhard Garhofer

Ass. Prof. PD. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerhard Garhoefer, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna

Locations

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

OPHT-120312

Identifier Type: -

Identifier Source: org_study_id