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

NCT01579539 | Completed Phase 3 DMC

• 1 other identifier: OPHT-120312
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Keywords

Methylprednisolone; Dry Eye Syndrome; Tear Film; Thyroid-associated ophthalmopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Break up time (BUT)

  13 weeks

• Visual acuity

  13 weeks

• Tear film osmolarity

  13 weeks

• Degree of exophthalmia

  13 weeks

• Palpebral fissure width

  13 weeks

Study Arms (1)

Patients

EXPERIMENTAL

Patients with moderate to severe thyroid-associated ophthalmopathy

Drug: Methylprednisolone; Drug: Esomeprazole

Interventions

Methylprednisolone DRUG

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

Patients

Esomeprazole DRUG

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

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Graves Ophthalmopathy; Dry Eye Syndromes

Interventions

Methylprednisolone; Esomeprazole

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Gerhard Garhoefer, MD

  Department of Clinical Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof. PD. Dr.

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 18, 2012
• Study Start: June 27, 2013
• Primary Completion: May 18, 2017
• Study Completion: May 18, 2017
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

AU (1)